[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Proposed Rules]
[Pages 12147-12169]
[FR Doc No: 2019-05822]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1000, 1002, 1010, 1020, 1040, and 1050

[Docket No. FDA-2018-N-3303]
RIN 0910-AH65

Radiological Health Regulations; Amendments to Records and
Reports for Radiation Emitting Electronic Products; Amendments to
Performance Standards for Diagnostic X-Ray, Laser and Ultrasonic
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY:  The Food and Drug Administration (FDA, Agency, or we) is
proposing to amend and repeal parts of the radiological health
regulations covering recommendations for radiation protection during
medical procedures, certain records and reporting for electronic
products, and performance standards for diagnostic x-ray systems and
their major components, laser products, and ultrasonic therapy
products. The Agency is proposing this action to clarify and update the
regulations to reduce regulatory requirements that are outdated and
duplicate other means to better protect the public health against
harmful exposure to radiation emitting electronic products and medical
devices. This action is part of FDA's implementation of Executive
Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively
reviewing existing regulations to identify opportunities for repealing
and amending regulations that will result in meaningful burden
reduction while allowing the Agency to achieve our public health
mission and fulfill statutory obligations.

DATES: Submit either electronic or written comments on this proposed
rule by July 1, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 1, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 1, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-3303 for ``Radiological Health Regulations; Amendments to
Records and Reports for Radiation Emitting Electronic Products;
Amendments to

Performance Standards for Diagnostic X-ray, Laser and Ultrasonic
Products.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert Ochs, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4312, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of Major Provisions
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Introduction
    B. FDA's Current Statutory Authority Framework
    C. Need for Amendments to the Regulations
IV. Legal Authority
V. Description of the Proposed Rule
    A. Scope
    B. Proposed Repeal of Radiation Protection Recommendations
    C. Proposed Amendments About Applications for Variances
    D. Proposed Amendments About Records and Reports
    E. Proposed Amendments About Diagnostic X-ray Systems and Their
Major Components
    F. Proposed Amendments About Laser Products
    G. Proposed Repeal of Ultrasonic Therapy Products Performance
Standard
VI. Proposed Effective Date
VII. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
    C. Summary of Regulatory Flexibility Analysis
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Proposed Rule

    This proposed rule would amend and repeal certain regulations for
radiation emitting electronic products and medical devices because FDA
has identified the regulations as being outdated and duplicative of
other means for reducing radiation exposure to the public. The Agency
is proposing to update the regulations to reduce regulations that are
outdated and otherwise clarify requirements for protecting the public
health against radiation exposure from specific electronic products and
medical devices. The regulations being proposed for amending or
repealing are the radiation protection recommendations for specific
uses, records and reporting requirements for electronic products,
applications for variances, and performance standards for diagnostic x-
ray systems and their major components, laser products, and ultrasonic
therapy products.

B. Summary of the Major Provisions of the Proposed Rule

    This proposed rule, when finalized, will update FDA's radiological
health regulations to amend or repeal the following radiological health
(21 CFR parts 1000 to 1050) parts of the general provisions:
     Repeal the radiation protection recommendations that have
become outdated and unnecessary due to current FDA safety
communications and other mechanisms that can provide more comprehensive
recommendations to protect patients and health professionals from
unnecessary radiation exposure;
     Amend the records and reporting requirements for
electronic products and medical devices by removing or reducing some of
the annual reports and test record requirements that are unnecessary or
may be duplicative of other reporting requirements by FDA and State
regulators;
     Revise the timing for submissions of reporting
requirements for accidental radiation occurrences (AROs) to allow
quarterly reporting for AROs that are not associated with a death or
serious injury;
     Amend the applications for variances process to no longer
require a manufacturer to submit two additional copies with the
original documents;
     Amend the regulations to no longer require assemblers who
install certified components of diagnostic x-ray systems to submit
reports of assembly to the Agency. FDA is proposing to amend the
regulations to require assemblers to submit assembly reports only to
the purchaser, and, where applicable, to State agencies responsible for
radiation protection because the Agency no longer uses the reports to
plan routine inspections of newly assembled equipment;
     Amend the performance standard for laser products by
reducing the regulatory requirements for: (1) Uncertified laser
products that are intended to be used as a component and are
incorporated into an electronic product that is then certified by the
manufacturer of a finished electronic product and (2) certified and
unmodified laser products that are not intended for use as a component
or replacement and that are incorporated into another product; and
     Repeal the performance standards for sonic, infrasonic,
and ultrasonic products because they are limited to a subset of
physical therapy devices with an outdated standard. The Agency
considers the premarket medical device regulations to be sufficient to
ensure the

safety of ultrasonic therapy products. The current Electronic Product
Radiation Control (EPRC) reporting for initial, abbreviated, and annual
reports of ultrasonic products is also duplicative given the more
comprehensive medical device regulations and premarket authorizations
for these products.
    The Agency believes the amendments in this proposed rule will help
ensure that the requirements for radiation emitting electronic products
and devices will continue to protect the public health and safety while
reducing regulatory burdens.

C. Legal Authority

    FDA is issuing this proposed rule under the same authority under
which FDA initially issued these regulations, the device and general
administrative provisions of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 321, 351, 352, 360, 360e-360j, 360hh-360ss, 371,
374, and 381). FDA has the authority under section 534 of the FD&C Act
(21 U.S.C. 360kk) to amend the performance standard for diagnostic x-
ray systems and their major components, amend the performance standard
for laser products, and repeal radiation protection recommendations and
the performance standard for ultrasonic therapy products, as provided
for in this proposed rule.

D. Costs and Benefits

    This proposed rule will update FDA's radiological health
regulations by amending parts of the general provisions including
records and reporting requirements for electronic products. Benefits
are estimated in terms of cost savings. Industry cost savings are
derived by estimating the savings in reduced labor resulting from the
reduction in reporting, recordkeeping, and third-party disclosure
requirements. Cost savings to FDA result from the reduction in labor
hours required to review reports. The total present value cost savings
over a 20-year time period are $62.8 million at a 7 percent discount
rate and $88.2 million at a 3 percent discount rate. Annualized total
cost savings are $5.93 million. We estimate the costs to read the rule
for all reporting respondents. The present value costs are $1.47
million and the annualized costs calculated over a 20-year time period
are $0.14 million at a 7 percent discount rate and $0.10 million at a 3
percent discount rate.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

Accidental Radiation Occurrences.....  ARO
Center for Devices and Radiological    CDRH
 Health.
Centers for Medicare & Medicaid        CMS
 Services.
Conference of Radiation Control        CRCPD
 Program Directors.
Executive Order......................  EO
Electronic Product Radiation Control.  EPRC
Environmental Protection Agency......  EPA
Federal Food, Drug, and Cosmetic Act.  FD&C Act
Food and Drug Administration.........  FDA, Agency or we
International Commission on            ICRP
 Radiological Protection.
International Electrotechnical         IEC
 Commission.
Medical Device Reporting.............  MDR
National Council on Radiation          NCRP
 Protection and Measurements.
Radiation Control for Health and       RCHSA
 Safety Act.
Quality Assurance....................  QA
Technical Electronic Product           TEPRSSC
 Radiation Safety Standards Committee.

III. Background

A. Introduction

    Pursuant to EOs 13771 and 13777 (Refs. 1-2), FDA has conducted a
comprehensive review of the requirements and recommendation of
electronic products based on their level of radiation exposure. FDA
recognizes that some records and reporting requirements for some
radiation emitting electronic products and medical devices are not
necessary to protect the public health and safety in compliance with
the EPRC program (see sections 532, 534(a)(1), and 537(b) of the FD&C
Act; 21 U.S.C. 360ii, 360kk(a)(1), and 360nn(b)). In addition, some of
the recommended protections against radiation and performance standards
are now outdated and redundant to other Federal and State requirements
as practitioners and industry rely on numerous current radiation
guidance documents, along with industry standards, to ensure the public
health. For example, FDA recognizes that submission of quarterly
reports is unnecessary given certain annual reporting requirements. The
submission of initial product reports for products that are also
subject to premarket authorization prior to marketing is duplicative.
The recommended protections against radiation are now outdated and
redundant to other Federal and State requirements and professional
guidelines that apply to the education and licensing of practitioners
(Refs. 3-7). Also, there are more recent standards that industry and
FDA can rely on for the safety of ultrasonic therapy devices for
physical medicine, for instance the International Electrotechnical
Commission (IEC) standards 60601-2-5 and 61689.
    In addition, in the Federal Register of September 8, 2017 (82 FR
42494), FDA published a notice for request for comments and information
on the ``Review of Existing Center for Devices and Radiological Health
Regulatory and Information Collection Requirements'' that could be
amended, repealed or replaced to achieve meaningful burden reduction
while achieving FDA's public health mission. FDA received comments
regarding the radiological health regulations and its performance
standards. As a result, FDA is proposing to amend its regulations for
requirements for certain reporting and records of electronic products
by removing or reducing certain reporting, as well as repealing
outdated recommendations for radiation protection and performance
standards, to alleviate regulatory burden to both FDA and industry.

B. FDA's Current Statutory Framework

    The FD&C Act (21 U.S.C. 301 et seq.), as amended, establishes a
comprehensive system for the regulation of devices intended for human
use.
    The Safe Medical Devices Act of 1990 (Pub. L. 101-629), enacted on
November 28, 1990, transferred the provisions of the Radiation Control
for Health and Safety Act of 1968 (Pub. L. 90-602) (formerly 42 U.S.C.
263b through n(i) et seq.) from Title III of the Public Health Service
Act to Chapter V, subchapter C of the FD&C Act, entitled ``Electronic
Product Radiation Control'' (21 U.S.C. 360hh-360ss). Under these
provisions, FDA administers the EPRC program to

protect the public health and safety. This authority provides for
developing, amending, and administering radiation safety performance
standards for electronic products.
    Under the FD&C Act, the EPRC applies to any electronic product that
is defined as: (a) Any manufactured or assembled product (or component,
part, or accessory of such product) which, when in operation, (i)
contains or acts as part of an electronic circuit and (ii) emits (or in
the absence of effective shielding or other controls would emit)
electronic product radiation, or (b) any manufactured or assembled
article which is intended for use as a component, part or accessory of
a product described in clause (A) and which when in operation emits (or
in the absence of effective shielding or other controls would emit)
such radiation (see section 531(2) of the FD&C Act, 21 U.S.C.
360hh(2)).
    Electronic product radiation is defined as: (a) Any ionizing or
non-ionizing electromagnetic or particulate radiation or (b) any sonic,
infrasonic, or ultrasonic wave, which is emitted from an electronic
product as the result of the operation of an electronic circuit in such
product (section 531(1) of the FD&C Act). Some products may fall under
the definition of both a medical device and an electronic product (see
section 201(h) of the FD&C Act for definition of a device and section
531(2) of the FD&C Act for definition of electronic product). As such,
these products may be subject to the provisions of the FD&C Act and
FDA's regulations that apply to medical devices and electronic
products.
    The EPRC program also directs FDA to prescribe performance
standards for electronic products to control the emission of electronic
product radiation. In establishing performance standards consistent
with the statute, FDA consults with the Technical Electronic Product
Radiation Safety Standards Committee (TEPRSSC), established under the
Radiation Control for Health and Safety Act (RCHSA). The TEPRSSC
functions to provide advice and consultation to FDA on the technical
feasibility, reasonableness, and practicality of all proposed
performance standards for electronic products (section 534(f) of the
FD&C Act) (Ref. 8). FDA submits to TEPRSSC a proposed standard or
amendment of a performance standard for an electronic product before
issuing a proposed regulation in the Federal Register containing such
standard or amendment of such standard (section 534(f)(1)(A) of the
FD&C Act). TEPRSSC may also recommend electronic product radiation
safety standards to FDA (section 534(f)(1)(B) of the FD&C Act).
    Upon receipt of advice from TEPRSSC, responsibility for action on
creating or updating performance standards rests with FDA (21 CFR
14.122(b)). Based on this advice, the creation, amendment, and
revocation of performance standards for electronic products to control
the emission of electronic product radiation are accomplished by
rulemaking, including the opportunity for notice and comment (section
534(a)-(b) of the FD&C Act).
    On October 26, 2016, a TEPRSSC meeting was held and FDA presented,
for consultation with TEPRSSC, proposed certain amendments to the
regulations for laser, sonic, x-ray, and other radiation emitting
products to best align FDA's focus with the public health need and
reduce or eliminate standards or reporting that were no longer
considered necessary (Sec.  1040.10(a)) (Ref. 9). FDA also proposed to
the TEPRSSC the removal of the ultrasonic therapy performance standard
with continuing reliance on medical device review prior to marketing
authorization. Items in these proposed amendments have been considered
by TEPRSSC discussions as necessary.

C. Need for Amendments to the Regulations

    FDA is responsible for protecting and promoting the public health
regarding electronic product radiation from medical devices and
electronic products. Voluntary consensus standards regarding safety and
essential performance have been developed and continually improved to
increase the safety of these devices. FDA believes radiation emitting
electronic products and devices that comply with Federal standards
provide a reasonable assurance of safety and effectiveness when
properly used by trained personnel, and concern has shifted to
minimizing improper uses. FDA, patients, health workers, and industry
recognize that medical products that emit radiation should be used only
when medically justified to answer a clinical question or to guide
treatment of a disease, and that the amount of radiation used should be
limited to that necessary to accomplish the clinical task. (Refs. 3,
10-12).
    In 2010, FDA's Center for Devices and Radiological Health (CDRH)
launched an ``Initiative to Reduce Unnecessary Radiation Exposure from
Medical Imaging'' (Ref. 13) to protect public health by promoting the
appropriate use of radiation and safety features to minimize
unnecessary radiation exposure from medical imaging. Through this
initiative, FDA collaborates with other agencies and the health care
professional community to mitigate factors contributing to unnecessary
patient exposure to radiation during medical procedures. The range of
electronic products marketed today is diverse with regards to radiation
emission levels, product complexity, consumer use, and sales volume.
The public risk associated with exposure to radiation from these
products also varies significantly; however, the risks to patients can
be mitigated by medical personnel only performing exams using radiation
when necessary to answer a medical question, treat a disease or guide a
procedure (Ref. 14). In accordance with FDA's directive to carry out
the EPRC program, FDA has determined that the regulatory requirements
can be adjusted to take account of the wide range of electronic
products currently on the market and focus on products that pose a
higher risk to the public.
1. Radiation Protection Recommendations
    Between 1976 and 1980, FDA issued final voluntary recommendations
to provide industry and practitioners with recommendations for
radiological protection for specific medical procedures (see 44 FR
71728 at 71729). In the Federal Register of July 23, 1976 (41 FR
30327), FDA set forth recommendations for use of specific area gonad
shielding on patients during medical diagnostic x-ray procedures. In
the Federal Register of December 11, 1979 (44 FR 71728), FDA issued a
final recommendation for the voluntary establishment of quality
assurance (QA) programs by all diagnostic facilities. FDA encouraged
each facility to implement only those recommendations that the facility
determined would lead to benefits in improved image quality, reduced
radiation exposure, and/or reduced costs sufficient to compensate for
the costs of the action. A facility can use its QA program to optimize
radiation dose for each kind of x-ray imaging examination, procedure,
and medical imaging task the facility performs (Refs. 3-4, 14). In the
Federal Register of June 17, 1980 (45 FR 40976), FDA issued a final
recommendation on administratively required dental x-ray examinations.
FDA recommended that dental x-ray examinations only be performed after
careful consideration of the dental or other health needs of the
patient, based on medical judgement necessary for diagnosis, treatment,
or prevention of disease. Dental radiography is estimated to contribute
much less than one percent of the total

population's exposure to all types of radiation (medical and non-
medical) (Ref. 15).
    Since the publication of the recommendations over the last 30
years, numerous other organizations and Federal and State agencies have
developed more comprehensive recommendations on patient shielding,
quality control, and the safe use of x-ray imaging in dentistry. FDA
recognizes the significant and ongoing contributions that external
stakeholders, such as the American Association of Physicists in
Medicine, the American College of Radiology, the Health Physics
Society, the Image Gently Alliance, the International Atomic Energy
Agency, the Medical Imaging Technology Alliance, the Society of
Interventional Radiology, the World Health Organization, and many
others, have made to incorporate radiation protection into device
design, practitioner training, and best practices for standards of
care. There are communities of scientific and clinical experts, often
with FDA collaboration, dedicated to developing radiation safety
training programs and setting qualification and accreditation standards
by users and facilities that are adequate to supersede FDA
recommendations. For example, in 2003, the National Council on
Radiation Protection and Measurements (NCRP) updated its
recommendations on radiation protection in dentistry (Ref. 4). In 2012,
the American Dental Association, in conjunction with FDA, updated its
selection criteria for dental imaging with guidelines for the frequency
of dental radiographs and radiation exposure recommendations (Ref. 5).
In 2014, the Environmental Protection Agency's (EPA) Working Group on
Medical Radiation, with active FDA participation, published a document
entitled ``Federal Guidance Report No. 14. Radiation Protection
Guidance for Diagnostic and Interventional X-Ray Procedures'' (Guidance
Report No. 14), which provides comprehensive recommendations for
radiation protection to medical and dental facilities (Ref. 3).
    Also, over the last decade FDA has been actively engaged with other
State agencies to develop and publish more modern recommendations than
those identified under FDA's regulations to promote and protect public
health by reducing unnecessary radiation exposure from medical imaging
(part 1000 (21 CFR part 1000)). These efforts were in response to
increasing use of ionizing radiation for medical imaging highlighted in
the NCRP Report No. 160 (Ref. 15). FDA strives to promote patient
safety through the principles of radiation protection developed by the
International Commission on Radiological Protection (ICRP) (Ref. 16).
For example, FDA actively works with States, which have the authority
to regulate diagnostic radiology facilities. FDA routinely provides
input into the model State regulations (the Suggested State
Regulations) developed by the Conference of Radiation Control Program
Directors (CRCPD), which include suggested regulations relating to the
use of x-ray imaging in medicine and dentistry and diagnostic imaging
quality assurance (Ref. 17). In addition, the Centers for Medicare &
Medicaid Services (CMS) requires advanced diagnostic imaging services
to be accredited by a designated accrediting organization in order to
receive Medicare reimbursement. Practitioner training and radiation
safety are part of the accreditation requirements (Ref. 18).
    FDA has and will continue to participate actively in the
development and maintenance of safety standards related to radiation
protection, including IEC standards for radiography and fluoroscopy,
computed tomography, interventional fluoroscopy, dental radiography,
radiation therapy, laser products, and microwave ovens, among others.
Manufacturers are required to conform with these standards in order to
market their device in some countries, including China and Europe. Our
participation in standards development is critical to advocating for
industry-wide implementation of radiation protection safety features
that result in a benefit to the public health and facilitates global
harmonization of safety measures for radiation therapies. FDA also has
and retains its authority over medical device premarket reviews,
surveillance, and compliance programs--as well as the other EPRC
reporting requirements and performance standards--to address radiation
safety issues with respect to medical devices.
    In view of FDA's continuous collaboration with States, other
Federal agencies, and professional organizations, FDA has determined
that the recommendations in FDA's current regulations for radiation
protection during medical procedures (part 1000) are obsolete and do
not address many aspects of modern radiation control and QA as
articulated in more contemporary guidelines and is proposing that the
recommendations be repealed. For example, the regulations for radiation
emitting products provide recommendations for QA programs for imaging
using film, but almost no current facilities still use film (Sec.
1000.55(c)(3)). FDA is proposing that it is unnecessary to revise the
film quality control recommendations for new digital imaging equipment
because FDA performs premarket authorization review of the digital x-
ray equipment, which includes a review of the manufacturer's device
labeling proposed to support a reasonable assurance of safety and
effectiveness (see 21 CFR part 892). The performance standards that
apply to the x-ray imaging products also still apply (see Sec. Sec.
1020.30 and 1020.31 (21 CFR 1020.30 and 1020.31)). When used as
intended by trained practitioners, FDA believes that digital equipment
can provide more reliable high-quality images with greater potential to
lower radiation exposure. As discussed above, FDA believes there are
adequate recommendations and guidelines available to provide sufficient
guidance on the safe use of medical x-ray modalities.
    Therefore, FDA is proposing to repeal the radiation protection
recommendations in the regulation because these recommendations have
become outdated and there is no longer a need for FDA to specify and
maintain a set of recommendations for practitioners. FDA encourages
practitioners to review and apply the most current guidelines developed
by professional societies (see the list of agencies and societies
listed earlier in this section), along with the medical device labeling
to ensure radiation protection. In addition to continued active
participation in consensus standards development, FDA can also utilize
its authority over device labeling and will continue to review device
labeling for adequate directions for use of the product (see Sec.
801.5 (21 CFR 801.5)). FDA will also continue its participation on
collaborative efforts with stakeholders who are engaged in developing
radiation safety education and standards for patient care. FDA will
continue to amend specific FDA performance standards as appropriate to
include aspects of radiation protection or reporting that are not
already addressed by consensus standards.
2. Applications for Variances
    FDA may grant a variance from one or more provisions of any
performance standard under certain conditions. Upon application of
variances or for amendments or extensions of variances, FDA requires
manufacturers or assemblers to submit one original and two copies of
the application to the Agency (Sec.  1010.4(b) (21 CFR 1010.4(b))).
When FDA receives a new application for variance, the Agency's Dockets
Management Staff will scan the original application electronically into
the

docket for a specific submission. FDA has determined that the
requirement for multiple copies is no longer necessary because the
docket maintains an electronic version of the application and it is an
unnecessary regulatory burden on manufacturers to require additional
copies. Therefore, FDA is proposing to amend the applications for
variances section to only require a manufacturer to submit the original
to the Dockets Management Staff.
3. Records and Reports
    The range of electronic products marketed today is diverse
regarding radiation emission levels, product complexity, consumer use,
and sales volume. FDA receives a large volume of records and reports
both annually and quarterly from manufacturers of electronic products
(Sec.  1002.1 (21 CFR 1002.1)). Industry has previously raised concerns
about redundancy of information that FDA requires to be submitted to
comply with both the medical device regulations and EPRC regulations
for products that are both medical devices and electronic products. In
the Federal Register of September 19, 1995 (60 FR 48374), FDA issued a
final rule amending the regulations regarding requirements for
recordkeeping and reporting of adverse events and other information
related to radiation emitting electronic products. This rule reduced
the recordkeeping and reporting requirements for some products,
required only abbreviated reporting for other products, and clarified
certain requirements.
    Based on additional experience with these products and knowledge of
their radiation risks, FDA has concluded that the record and reporting
requirements for these products should be tailored to focus upon
products that have the potential to pose greater risk, while reducing
regulatory burdens on manufacturers, dealers and distributors of
radiation emitting electronic products that pose less risk to public
health (Sec.  1002.1). FDA also considered what categories of EPRC
reports were duplicative of information that would be submitted to FDA
in a premarket review of the safety and effectiveness of a new medical
device. For example, an initial or abbreviated product report for an
ultrasound or x-ray system is duplicative if the firm is also expected
to submit a premarket 510(k) notification for a new ultrasound or x-ray
system that contains the same (or more detailed) information related to
radiation safety features and performance. In general, current record
and reporting requirements will remain for those products that emit the
highest radiation levels or are sold in the largest quantities because
they present the greatest potential risks to public health. For those
products that present the least public health risk or for categories of
medical-devices that FDA considers the EPRC reporting to be duplicative
given the medical device regulations, FDA is proposing to reduce
reporting requirements.
    In addition, FDA has identified medical and non-medical sonic
products for which FDA believes record and reporting requirements
should no longer be required. FDA believes the current record and
reporting requirements for some electronic products, including
ultrasonic therapy products, are an unnecessary burden and a source of
confusion for these products. As a result, FDA is proposing to amend
the record and reporting requirements to no longer require product
reports, supplemental reports, abbreviated reports, annual reports,
test records, or distribution records for certain products (see revised
table 1 of Sec.  1002.1).
    FDA is proposing to remove the requirement for manufacturers to
report model numbers of new models of a model family that do not
involve changes in radiation emission or requirements of a performance
standard in quarterly updates to their annual reporting (Sec.  1002.13
(21 CFR 1002.13(c))). FDA has determined that quarterly reporting of
new models is unnecessary. The submission of annual reports is
sufficient to provide FDA with periodic information to regulate these
products, and the submission of quarterly reports has been an
unnecessary burden on industry. Generally, FDA requires specified
product manufacturers to submit annual reports to the Agency that
summarize certain manufacturing records (see Sec.  1002.13(a) and (b)).
FDA is not amending these annual report requirements; however, FDA has
determined that requiring select manufacturers to submit quarterly
updates to FDA in addition to the annual report, is no longer necessary
to protect the public health and safety.
    FDA believes that the revisions to the reporting and recordkeeping
are reasonable based on the risk of certain product categories (Sec.
1002.1). However, FDA is seeking public comments on other possible
revisions to table 1 that may simplify the reporting requirements based
on a reduction of unnecessary or duplicative reporting (Sec.  1002.1).
    Lastly, FDA is proposing amendments to AROs by allowing any
manufacturer of a radiation emitting electronic product to submit
quarterly summary reports of AROs that are not associated with a death
or serious injury (21 CFR 803.3(w)) and not required to be reported
under the medical device reporting regulations (Sec.  1002.20 (21 CFR
1002.20); 21 CFR part 803). Manufacturers of electronic products are
currently required, where reasonable grounds are suspected, to
immediately report to FDA all AROs reported to or otherwise known to
the manufacturer and arising from the manufacturing, testing, or use of
any product introduced or intended for introduction into commerce by
the manufacturer (Sec.  1002.20). FDA believes that amending the
regulations to allow summary reporting for AROs not associated with a
death or serious injury for electronic products extends the approach of
eliminating or reducing duplicative reporting requirements beyond the
medical device arena and promotes harmonization between this reporting
and the new voluntary malfunction summary reporting program for medical
devices (see part 803). In the Federal Register of August 17, 2018, FDA
published the ``Voluntary Malfunction Summary Reporting Program''
Notice identifying the criteria and format for summary reporting in the
quarterly reports for device malfunctions that will also be applicable
to AROs (83 FR 40973). FDA is seeking public comments from
manufacturers as to whether quarterly summary reports would reduce
burden, and whether manufacturers have additional suggestions as to the
specificity in the format, content, or timing of summary reports.
4. Diagnostic X-Ray Systems and Their Major Components
    The purpose of the performance standard for diagnostic x-ray
systems is to protect the public health by reducing unnecessary
exposure to ionizing radiation while assuring the clinical utility of
the images produced. In the Federal Register of June 10, 2005 (70 FR
33998), the FDA issued a final rule to amend the Federal performance
standard for diagnostic x-ray systems and their major components (i.e.,
the performance standards). Under those regulations, the performance
standard requires that assemblers who install certified components of
diagnostic x-ray systems must assemble, install, adjust, and test the
certified components according to the instructions of the component
manufacturer when these certified components are installed into a
diagnostic x-ray system (Sec.  1020.30(d)). In addition, assemblers are
responsible for filing a report of the assembly that affirms the
manufacturer's instructions

were followed in the assembly or that the certified components as
assembled into the system meet all applicable requirements of
Sec. Sec.  1020.30 through 1020.33 (Sec.  1020.30(d)(1)).
    Currently, all assembler reports must be on a form prescribed by
CDRH and submitted to the Director of CDRH, to the purchaser, and,
where applicable, to the State agency responsible for radiation
protection within 15 days following assembly. FDA has determined that
the reports of assembly are important for State agencies and the
purchasers, but reporting to FDA is an unnecessary additional burden to
the manufacturer as FDA is no longer using these reports to plan
routine inspections of newly assembled equipment. Therefore, FDA is
proposing to amend the regulation to remove the requirement that a
manufacturer must submit a report of assembly of a certified component
to the Agency. While FDA no longer needs the report to plan routine
inspections of installed x-ray systems, other requirements in the
performance standard for x-ray systems and their major components are
unchanged. FDA also plans routine inspections of the x-ray equipment
manufacturers for compliance with the quality system regulations (see
21 CFR part 820).
    X-ray systems and certain components are still subject to FDA
premarket review (see part 892). Compliance with FDA regulations and
post-market surveillance allows monitoring the safety of installed
equipment through medical device reporting (MDRs) (part 803), recalls
(see 21 CFR part 806), notifications of defects (see 21 CFR part 1003),
and reporting of accidental radiation occurrences (see Sec.  1002.20).
FDA believes that, as was previously described, the history of
continuous efforts to reduce unnecessary radiation among manufacturers
and practitioners, consensus standards development, and other
regulatory authorities for compliance and surveillance all support
FDA's conclusion that reports of assembly no longer need to be
submitted to FDA. FDA has found the information received and reviewed
in MDRs, recalls, and other means to be sufficient for ongoing efforts
to inform consensus standards development, guidance, or collaboration
on improved education as a better use of resources to result in a
broader impact to reduce unnecessary radiation exposure and protect the
public health and safety.
5. Laser Products
    On December 18, 1989, in response to numerous questions regarding
the applicability of regulations on laser products, and modification of
a certified laser product, in situations in which a firm purchases a
certified Class I laser product and incorporates it into another
product for sale (Sec.  1040.10(i) (21 CFR 1040.10(i))), FDA issued
``Laser Notice No. 42--Clarification of Compliance Requirements for
Certain Manufacturers Who Incorporate Certified Class I Laser Products
Into Their Products'' (Laser Notice No. 42) (Ref. 19). In Laser Notice
No. 42, FDA announced its policy that it will consider firms that
incorporate unmodified, certified Class I laser products into another
product to be distributors of laser products certified and reported by
other manufacturers provided certain conditions were met. If this
proposed rule is finalized, the exception from applicability of laser
performance standards will be expanded to include all classes of
certified and unmodified laser products (Class I, II, IIa, IIIa, IIIb,
and IV) that are not intended for use as a component or replacement and
that are incorporated into another product (see proposed amendment
Sec.  1040.10(a)(2)). These amendments, if finalized, will further
streamline the regulation of finished certified laser products that are
installed into another product, while providing for the same protection
of the public health and safety from electronic product radiation from
laser products as originally certified.
    The proposed rule does not change the requirements for distributors
of laser products. Distributors of laser products need not submit
initial and annual reports nor apply new certification and
identification labels to the outside of the final product (Sec. Sec.
1010.2 and 1010.3), which remain the responsibility of the
manufacturer. Instead, distributors of laser products must only comply
with the recordkeeping requirements (Sec. Sec.  1002.40 and 1002.41 (21
CFR 1002.40 and 21 CFR 1002.41)).
    At the same time, FDA is retaining the exception from applicability
of the laser product performance standard for uncertified laser
products intended to be used as a component or replacement for an
electronic product that is then certified by the manufacturer of such
finished electronic product (see Sec.  1040.10(a)). Specifically, the
laser product performance standards will still not apply to
manufacturers of uncertified laser products intended to be used as a
component or replacement in a finished electronic product that is then
certified by the manufacturer, subject to certain conditions (see
proposed amendment Sec.  1040.10(a)(1)(i)-(iii)). To clarify, Sec.
1040.10(a)(1), as proposed to be amended, describing laser products
intended for use as components and excepted from the laser performance
standard and the associated reporting and recordkeeping requirements
found in part 1002 remain unchanged by these amendments.
    Such exception from the laser product performance standards
continues to not apply to removable laser systems, which must comply
with the laser product performance standards as well as applicable
reporting and recordkeeping requirements. Removable laser systems are
designed to be incorporated in such a way that they may be removed
without modification and still be capable of producing laser radiation
when powered by a general energy source, such as those provided by wall
transformers, batteries, or other AC or DC power (see Sec.
1040.10(c)(2)).
    Lastly, FDA is amending the Agency's address for registration and
listing for manufacturers of uncertified laser products that are
intended to be used as a component and are incorporated into an
electronic product (see proposed amendment Sec.
1040.10(a)(1)(iii)(A)).
6. Ultrasonic Therapy Products
    Ultrasonic therapy products are both devices, under section 201(h)
of the FD&C Act, and electronic products, under section 531(2) of the
FD&C Act. In the Federal Register of February 17, 1978 (43 FR 7166),
FDA issued a final rule establishing a radiation performance standard
for ultrasonic therapy products for use in physical therapy
manufactured on or after February 17, 1979. The standard applies to any
device intended to generate and emit ultrasonic radiation for
therapeutic purposes at frequencies above 16 kilohertz and to
generators or applicators designed or specifically designed for use in
such devices. Ultrasonic therapy devices currently must comply with the
general performance standards for electronic products (part 1010), and
the performance standard for ultrasonic therapy products (Sec.  1050.10
(21 CFR 1050.10)). The performance standard for ultrasonic therapy
products only applies to ultrasonic therapy products for use in
physical therapy, but not the range of other therapeutic medical
ultrasound devices. Ultrasonic therapy products, also known as
diathermy products, are intended to generate therapeutic deep heat
within body tissues for the treatment of selected medical conditions.
The safety profile of medical ultrasound products is reviewed prior to
marketing authorization to consider their intended uses by trained
professionals who follow the manufacturer's labeling, which labeling

is required to provide adequate directions for use (Sec.  801.5).
    Since the time that ultrasonic therapy performance standards were
finalized in 1979, other regulations now apply to the safety and
effectiveness of ultrasonic therapy products. The products are subject
to premarket authorization (see Sec.  890.5300 (21 CFR 890.5300)).
Additionally, FDA can perform routine inspections of the device
manufacturers for compliance with quality system regulations (see part
820). Compliance with FDA's regulations and post-market surveillance
also allow monitoring for the safety of equipment through medical
device reporting (MDRs) (see part 803) and recalls (see part 806). EPRC
notifications of defects (see part 1003) and reporting of accidental
radiation occurrences (see Sec.  1002.20) still apply. FDA finds that
the history of safe use, consensus standards development, and other
regulatory authorities for compliance and surveillance are adequate to
reduce the burden of also needing to comply with outdated performance
standards.
    The basis for development of the ultrasonic therapy performance
standards in 1979 is no longer relevant because FDA has since gained
authority to sufficiently monitor the quality and safety of ultrasonic
therapy products under the device premarket authorization review
process. The premarket authorization review can take into consideration
recognized IEC consensus standards and recommendations in applicable
FDA's guidance document(s) as an alternative to conformance with the
EPRC performance standards for the evaluation of the safety and
effectiveness of such products (Ref. 9). The premarket review can
determine substantial equivalence of the device performance and
labeling to a predicate product or premarket approval to demonstrate a
reasonable assurance of safety and effectiveness and adequate
directions for use (see Sec.  801.5).
    As a result, FDA is proposing to repeal the ultrasonic therapy
products performance standards because industry may conform to the
recognized IEC standards for these products, which provides at least
the same level of protection of the public health and safety from
electronic radiation as FDA performance standards, and provides greater
flexibility for changes in technology for ultrasonic therapy products.
The Agency has recommended through guidance that industry should
conform with IEC standards 60601-2-5 and 61689 to address the
performance standards for ultrasonic therapy (part 1050). Most of
industry already comply with these FDA recognized consensus standards.
FDA has published an ultrasonic diathermy device guidance entitled,
``Policy Clarification and Premarket Notification [510(k)] Submissions
for Ultrasonic Diathermy Devices; Guidance for Industry and Food and
Drug Administration Staff'' (Ref. 20). The guidance outlines a policy
that, if firms provide a declaration of conformity with the relevant
provisions of the current FDA recognized versions of the IEC 60601-2-5
and IEC 61689 standards, FDA does not intend to consider whether firms
comply with certain regulatory requirements (see Sec.  1050.10).
    FDA believes that the foregoing regulatory controls, such as
medical device premarket review, as well as quality controls,
surveillance, and recall authorities are adequate to monitor and
address safety issues that arise from any reports of adverse events
with these products. As a result, FDA is proposing to repeal the
performance standards for ultrasonic therapy products because these
standards apply to a limited subset of devices used in physical therapy
(see Sec.  890.5300) for which safety issues devices have been and will
continue to be handled through premarket regulatory review processes as
well as under other medical device regulatory authorities, such as MDRs
and device recalls.

IV. Legal Authority

    FDA is issuing this proposed rule under the same authority under
which FDA initially issued these regulations, the device and general
administrative provisions of the FD&C Act (21 U.S.C. 321, 351, 352,
360, 360e-360j, 360hh-360ss, 371, 374, and 381). FDA has the authority
under section 534 of the FD&C Act to amend the performance standard for
diagnostic x-ray systems and their major components, amend the
performance standard for laser products, and repeal radiation
protection recommendations and the performance standard for ultrasonic
therapy products, as provided for in this proposed rule.

V. Description of the Proposed Rule

A. Scope

    We are proposing to amend and repeal the parts of the radiological
health regulations covering recommendations for radiation protection
(part 1000), certain reporting and records of electronic products
(parts 1002, 1010, and 1020), and performance standards of laser
products (part 1040) and ultrasonic therapy devices (part 1050). These
proposed changes to the regulations are intended to reduce regulatory
requirements that are outdated and otherwise clarify requirements for
protecting the public health against exposure to specific radiation
emitting electronic products and medical devices. This action is part
of FDA's implementation of EOs 13771 and 13777.

B. Proposed Repeal of Radiation Protection Recommendations

    As stated above in section III, FDA believes there are adequate
recommendations from FDA, interagency work groups, and professional
organizations as well as State and accreditation/certification
requirements on practitioners and facilities to mitigate patients' and
health professionals' exposure to radiation from medical imaging. The
recommendations found in FDA's current regulations are now outdated and
can be removed without impacting public health, and practitioners and
industry can rely on more recent and comprehensive recommendations. FDA
is proposing to repeal the following regulations for radiation
protection recommendations: (1) Recommendation for the use of specific
area gonad shielding on patients during medical diagnostic x-ray
procedures (Sec.  1000.50), (2) recommendation for QA programs in
diagnostic radiology facilities (Sec.  1000.55), and (3) recommendation
on administratively required dental x-ray examinations (Sec.  1000.60).
Also, FDA is proposing to repeal the definition of phototherapy
products because it is no longer necessary with the removal of certain
reporting requirements identified in records and reports for radiation
emitting electronic products (Sec.  1000.3(s); see table 1 of Sec.
1002.1).

C. Proposed Amendment About Applications for Variances

    FDA has determined that it is unnecessary for manufacturers
submitting an application for variance to submit two copies of the
application in addition to the original (Sec.  1010.4(b)). Upon receipt
of a new application for variance by mail, FDA's Dockets Management
Staff will scan the original application electronically into the docket
for a specific submission; therefore, FDA is proposing to amend this
regulation by removing the requirement for manufacturers to submit two
additional copies of the application to Dockets Management Staff.
Applications for variance can also be submitted electronically through
the Regulations.gov website to Docket No. FDA-2013-S-0610 (https://
www.regulations.gov/docket?D=FDA-

2013-S-0610) as a new comment with an upload of the variance
application materials.

D. Proposed Amendments About Records and Reports

    FDA has reviewed the regulations and is proposing that certain
electronic product recordkeeping and reporting requirements are
unnecessary for protecting the public health and safety, and therefore
is proposing to simplify the applicability of the recordkeeping and
reporting requirements (part 1002). In addition, FDA is proposing to
change the frequency of some reports and recordkeeping, such as
quarterly reporting, because they are unnecessary requirements.
1. Table 1 Revision to Applicability
    FDA is proposing to amend the list of records and reports in table
1 to revise the applicability of the recordkeeping and reporting
requirements for some products (Sec.  1002.1). FDA recognizes that, for
some products, meeting the preexisting recordkeeping and reporting
requirements are not necessary for protection of the public health and
safety. The revisions will eliminate some requirements, clarify others,
and combine some reporting requirements identified in the table. For
instance, receiving reports for x-ray systems and ultrasonic systems is
redundant to the medical device premarket review, which provides FDA
more information on safety and effectiveness of an electronic product
and medical device. These proposed amendments, if finalized, will
improve protection of the public health and safety while reducing
regulatory burdens on manufacturers, dealers, and distributors of
radiation emitting electronic products. The amendments will remove
reports that FDA no longer considers necessary low-risk products, which
will allow better utilization of resources on high-priority aspects of
radiation safety for products with greater risk. Therefore, FDA
proposes to reduce recordkeeping and reporting requirements for some
products and clarify the applicability of certain requirements for
other products. The proposed revisions to table 1 are:
    a. Remove the following products from all of the record and
reporting requirements under part 1002: (a) Television products (Sec.
1020.10) with <25 kilovolt (kV) and >=25kV and <0.1 milliroentgens per
hour (mR/hr) isoexposure rate limit curve (IRLC), (b) phototherapy
products, and (c) acoustic products including ultrasonic therapy (Sec.
1050.10), diagnostic ultrasound, medical ultrasound other than therapy
or diagnostic, and nonmedical ultrasound. However, these proposed
amendments do not remove the general notification of defect
requirements for all electronic products (21 CFR part 1003) by
manufacturers. FDA believes removing the records and reporting
requirements for these types of low risk products will not undermine
the protection of the public health and safety. The medical device
reporting requirements (21 CFR part 803) and premarket notification
requirements (21 CFR part 807, subpart E) still apply to phototherapy
products and ultrasonic medical products. In the event there is an
issue with the product, FDA's general notification of defect
requirements and medical device regulations are sufficient for
providing FDA with necessary information.
    b. Remove the following products from the requirements for product
reports, supplemental reports and annual reports: (a) Computed
tomography, (b) x-ray systems, (c) tube housing assembly, (d) x-ray
control, (e) x-ray high voltage generator, (f) beam-limiting devices,
(g) spot-film devices and image intensifies manufactured after April
26, 1977, and (h) T lamps. However, these proposed amendments do not
remove the general notification of defect requirements for all
electronic products (21 CFR part 1003) by manufacturers. These devices
continue to be regulated under the medical device regulations,
including reporting requirements (21 CFR part 803) and premarket
notification requirements (21 CFR part 807, subpart E) for computed
tomography and x-ray systems. The reporting for T lamps is being made
consistent with R lamps as FDA believes the abbreviated reporting for R
and T lamps is sufficient for protection of the public health and
safety.
    c. Remove the following products from the requirements for
abbreviated reports: (a) X-ray table or cradle, (b) x-ray film charger,
(c) vertical cassette holders mounted in a fixed location and cassette
holders with front panels, (d) cephalometric devices manufactured after
February 25, 1978, and (e) image receptor support devices for
mammographic x-ray systems manufactured after September 5, 1978.
However, these proposed amendments do not remove the general
notification of defect requirements for all electronic products (21 CFR
part 1003) by manufacturers. These devices continue to be regulated
under the medical device regulations, including reporting requirements
(21 CFR part 803) and premarket notification requirements (21 CFR part
807, subpart E) for diagnostic x-ray systems and products. FDA believes
that submission of test records and distribution records and continued
regulation as medical devices is sufficient for protection of the
public health and safety.
    d. Remove the following products from the requirements for
abbreviated reports and annual reports: PRODUCTS INTENDED TO PRODUCE
PARTICULATE RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR CABINET
DIAGNOSTIC X-RAY (Medical). This reporting category is intended to
cover other medical devices that emit radiation, such as linear
accelerators. However, because there are no EPRC performance standards
for this category, these reporting requirements were primarily
informational only. FDA believes this reporting is unnecessary given
other FDA regulations to review and classify medical devices, including
premarket review to evaluate safety and effectiveness.
    e. Remove the following products from the requirements for
supplemental reports: (a) Television with >=0.1mR/hr IRLC 5, (b)
microwave ovens (Sec.  1030.10), and (c) class IIa, II, IIIa lasers and
products other than class I products containing such lasers.
Manufacturers of these products will continue to submit product reports
and annual reports, which FDA believes is sufficient for protection of
the public health and safety. FDA believes supplemental reporting is
unnecessary given the information reviewed in the product reports and
the relatively lower-risk of these products.
    f. Remove the T lamps products from the requirements for product
reports, supplemental reports, and annual reports and transfer the
product to the same category as R lamps. Manufacturers of T lamps
products will now instead be required to submit abbreviated reports,
which FDA believes promotes consistency for the two types of lamps and
provides sufficient oversight for protection of the public health and
safety.
    g. Remove ``diagnostic'' from ``Cabinet Diagnostic X-ray'' to match
the name of the standard ``Cabinet X-Ray.''
    The following proposed changes to table 1 of Sec.  1002.1 include
deletions that are indicated in a bold font and by a strikethrough and
replacements shown in bold font:
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    FDA is seeking public comments on other revisions to table 1 that
may simplify the table and reduce unnecessary or duplicative reporting
(Sec.  1002.1).
    2. Eliminating citation reserved.
    FDA is proposing to eliminate the citation reserve under Sec.
1002.2 because it is no longer necessary.
    3. Eliminating quarterly updates to the annual reports.
    FDA is proposing to eliminate the requirement for manufacturers to
report model numbers of new models of a model family that do not
involve changes in radiation emission or requirements of a performance
standard in quarterly updates to their annual reporting (Sec.
1002.13(c)). Generally, other subsections require specified product
manufacturers to submit annual reports to FDA which summarize certain
manufacturing records (Sec.  1002.13(a) and (b)). FDA is not amending
these annual reporting requirements.
    4. Reporting of AROs.
    FDA is proposing to amend the timing for submission of reporting
requirements for AROs that are not associated with a death or serious
injury (Sec.  1002.20). The proposed amendment will allow manufacturers
of a radiation emitting electronic product to submit quarterly summary
reports of AROs that are not associated with a death or serious injury
and not required to be reported under the medical device reporting
regulations (Sec.  1002.20; part 803). FDA believes that amending the
regulations to allow summary reporting for AROs for electronic products
extends the approach of eliminating or reducing duplicative reporting
beyond the medical device arena and promotes harmonization between this
reporting and the new voluntary malfunction summary reporting program
for medical devices (part 803; 83 FR 40973).

E. Proposed Amendment About Diagnostic X-ray Systems and Their Major
Components

    FDA is proposing to amend the reports of assembly requirements for
major components of diagnostic x-ray systems to no longer require
assemblers who install certified components to submit a report of
assembly, Form FDA 2579, to CDRH (Ref. 21) (Sec.  1020.30(d)). FDA will
withdraw the language to require submission to ``the Director'' in this
subsection, but will still publish a PDF form online for assemblers to
download, complete, and provide to applicable States and purchasers as
required.

F. Proposed Amendments About Laser Products

    FDA is proposing to amend the laser product regulations to clarify
and add exceptions to the applicability of the laser product
performance standards (see Sec. Sec.  1040.10 and 1040.11) to: (1)
Uncertified laser products that are intended to be used as a component
and are incorporated into an electronic product that is then certified
by the manufacturer of a finished electronic product and (2) a
manufacturer who incorporates an unmodified laser product into another
product when such laser product is not intended for use as a component
or replacement and such laser product is certified by the manufacturer
of such laser product, subject to certain conditions (Sec.
1040.10(a)). In addition, FDA is amending the Agency's address for
registration and listing for manufacturers of uncertified laser
products that are intended to be used as a component and are
incorporated into an electronic product (Sec.  1040.10(a)(1)). The new
address that manufacturers are required to submit their registration
and listing is the Director, Division of Radiological Health, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. G609, Silver Spring, MD 20993-
0002. Alternatively, reports may be submitted electronically through
FDA's eSubmitter (Ref. 22).

G. Proposed Repeal of Ultrasonic Therapy Products Performance Standard

    FDA is proposing to repeal the performance standard for ultrasonic
therapy products (Sec.  1050.10). The standard can be repealed because
it is limited to a subset of physical therapy devices with an outdated
standard in FDA's current regulations (see Sec.  890.5300), but for
which safety issues for these devices have been and will continue to be
handled through medical device premarket regulatory processes, as well
as under other medical device regulatory authorities, such as MDRs and
device recalls.

VI. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this
proposal become effective 30 days after the date of publication of the
final rule in the Federal Register.

VII. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under E.O. 12866,
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). EOs
12866 and 13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). E.O. 13771 requires that
the costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations'' (Ref. 1). We believe
that this proposed rule is not a significant regulatory action as
defined by E.O. 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. This proposed rule will reduce regulations that are outdated
and otherwise clarify existing requirements. Because the proposed rule
does not impose any additional regulatory burdens, we certify that the
proposed rule will not have a significant economic impact on a
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $150
million, using the most current (2017) Implicit Price Deflator for the
Gross Domestic Product. This proposed rule would not result in an
expenditure in any year that meets or exceeds this amount.

B. Summary of Costs and Benefits

    Benefits are estimated in terms of cost savings. Industry cost
savings are derived by estimating the savings in reduced labor
resulting from the reduction in reporting, recordkeeping, and third-
party disclosure requirements. Cost savings to FDA result from the
reduction in labor hours required to review reports. The total present
value cost savings over a 20-year time period are $62.8 million at a 7
percent discount rate and $88.2 million at a 3 percent discount rate.
Annualized total cost savings are $5.93 million. We estimate the costs
to read the rule for all reporting respondents. The present

value costs are $1.47 million and the annualized costs calculated over
a 20-year time period are $0.14 million at a 7 percent discount rate
and $0.10 million at a 3 percent discount rate.

                                     Table 2--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Period
                Category                     Primary    Low estimate      High      Year dollars    Discount       covered               Notes
                                            estimate                    estimate                    rate (%)       (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year.         $5.93         $5.93         $5.93          2016             7            20  ..........................
                                                 $5.93         $5.93         $5.93          2016             3            20
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Annualized Quantified...............  ............  ............  ............  ............             7  ............  None.
                                                                                3
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Qualitative.........................  ............  ............  ............  ............  ............         None.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year.         $0.14         $0.14         $0.14          2016             7            20  ..........................
                                                 $0.10         $0.10         $0.10          2016             3            20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Quantified...................  ............  ............  ............  ............             7  ............  ..........................
                                                                                3
Qualitative
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized          ............  ............  ............  ............             7  ............  None.
     $millions/year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          ............  ............  ............             3  ............  ............  ..........................
From/To.................................                    From:
                                                                    To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/     ............  ............  ............  ............             7  ............  None.
 year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          ............  ............  ............             3  ............
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To.................................                    From:
                                                                    To:
Effects:
--------------------------------------------------------------------------------------------------------------------------------------------------------
    State, Local, or Tribal Government:   ............
     No estimated effect..
    Small Business: No estimated effect.  ............
Wages: No estimated effect..............  ............
Growth: No estimated effect.............  ............
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with E.O. 13771, in table 3 we estimate present and
annualized values of costs and cost savings over an infinite time
horizon. Based on these cost savings, this proposed rule would be
considered a deregulatory action under E.O. 13771.

                                                             Table 3--EO 13771 Summary Table
                                               [In $ millions 2016 dollars, over a perpetual time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................           $1.47           $1.47           $1.47           $1.47           $1.47           $1.47
Present Value of Cost Savings...........................           84.65           84.65           84.65          197.52          197.52          197.52
Present Value of Net Costs..............................          -83.18          -83.18          -83.18         -196.05         -196.05         -196.05
Annualized Costs........................................            0.10            0.10            0.10            0.04            0.04            0.04
Annualized Cost Savings.................................            5.93            5.93            5.93            5.93            5.93            5.93
Annualized Net Costs....................................           -5.82           -5.82           -5.82           -5.88           -5.88           -5.88
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Summary of Regulatory Flexibility Analysis

    FDA has examined the economic implications of the proposed rule as
required by the Regulatory Flexibility Act. If a rule will have a
significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act requires agencies to analyze regulatory
options that would lessen the economic effect of the rule on small
entities. Because the proposed rule does not impose any additional
regulatory burdens, we certify that the proposed rule will not have a
significant economic impact on a substantial number of small entities.
    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 23) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and (i) and 25.34(c) that
this action is of a type that does not individually or cumulatively
have a significant effect on the human environment. Therefore, neither
an environmental assessment nor an

environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
The collections of information in parts 1002 through 1050 have been
approved under OMB control number 0910-0025, Electronic Products. The
amendments in this proposed rule, if finalized, necessitate revisions
to OMB control number 0910-0025. A description of revisions to the
annual reporting, recordkeeping, and third-party disclosure burden
estimates is given in the PRA, Description section of this document.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing each collection of information.
    Tables 4, 5, and 6 describe revisions to the burden estimates, as
well as the other information collections currently approved under OMB
control number 0910-0025. For the convenience of the reader, we have
noted for each information collection whether we are requesting
revision.
    FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Electronic Products.
    Description: FDA is proposing to amend its regulations for
requirements for certain reporting and records of electronic products
by removing specific reporting, as well as repealing outdated
recommendations for radiation protection and performance standards, and
removing submission requirements for copies of certain applications and
forms to alleviate regulatory burden to both FDA and industry.
    The records and reporting requirements for electronic products and
medical devices include annual reports and test records depending upon
the specific type of electronic product. FDA has determined upon review
of the records and reporting requirements that some of the requirements
are unnecessary or may be duplicative of other reporting requirements
by FDA and State regulators.
    Description of Respondents: The respondents to this information
collection are electronic product manufacturers, importers, and
assemblers of electronic products from private sector, for-profit
businesses.

                                                      Table 4--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
         Activity; 21 CFR section                     FDA form               Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response         \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product reports--1002.10(a)-(k) \3\.......  3639--Cabinet x-ray.........           1,149             2.2           2,529              24          60,685
                                            3632--Laser.................
                                            3640--Laser light show......
                                            3630--Sunlamp...............
                                            3659--TV....................
                                            3660--Microwave oven........
                                            3801--UV lamps..............
Product safety or testing changes--         ............................             440             2.5           1,100             0.5             550
 1002.11(a)-(b) \3\.                                                                                (30 minutes)
Abbreviated reports--1002.12 \3\..........  3629--General abbreviated                 54             1.8              97               5             485
                                             report.
                                            3663--Microwave products
                                             (non-oven).
Annual reports--1002.13(a)-(b) \3\........  3628--General...............           1,410             1.3           1,833              18          32,994
                                            3634--TV....................
                                            3641--Cabinet x-ray.........
                                            3643--Microwave oven........
                                            3636--Laser.................
                                            3631--Sunlamp...............
Accidental radiation occurrence reports--   3649--ARO...................              75               4             300               2             600
 1002.20 \3\.
Exemption requests--1002.50(a) and 1002.51  3642--General correspondence               4             1.3               5               1               5
 \4\.
Product and sample information--1005.10     2767--Sample product........               5               1               5             0.1               1
 \4\.                                                                                (6 minutes)
Identification information and compliance   2877--Imports declaration...          12,620             2.5          31,550             0.2           6,310
 status--1005.25 \4\.                                                                                (12 minutes)
Alternate means of certification--          ............................               1               2               2               5              10
 1010.2(d) \4\.
Variance--1010.4(b) \4\...................  3633--General variance                   350             1.1             385             1.2             462
                                             request.
                                            3147--Laser show variance
                                             request.
                                            3635--Laser show
                                             notification.

Exemption from performance standards--      ............................               1               1               1              22              22
 1010.5(c) and (d) \4\.
Alternate test procedures--1010.13 \4\....  ............................               1               1               1              10              10
Microwave oven exemption from warning       ............................               1               1               1               1               1
 labels--1030.10(c)(6)(iv) \4\.
Laser products registration--               3637--Original equipment                  70             2.9             203               3             609
 1040.10(a)(3)(i) \4\.                       manufacturer (OEM) report.
                                                                         -------------------------------------------------------------------------------
    Total.................................  ............................  ..............  ..............  ..............  ..............         102,744
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Total hours have been rounded.
\3\ We request revision of this information collection.
\4\ The burden estimate for this information collection is currently approved and included for the convenience of the reader. We do not request revision
  of this line item at this time.

                                Table 5--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
    Activity; 21 CFR section         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping        \2\
----------------------------------------------------------------------------------------------------------------
Manufacturers records--1002.30             1,409           1,650       2,324,850            0.12         278,982
 and 1002.31(a) \3\.............                                                     (7 minutes)
Dealer/distributor records--               2,909              50         145,450            0.05           7,273
 1002.40 and 1002.41 \3\........                                                     (3 minutes)
Information on diagnostic x-ray               50               1              50             0.5              25
 systems--1020.30(g) \4\........                                                    (30 minutes)
Laser products distribution                   70               1              70               1              70
 records--1040.10(a)(3)(ii) \4\.
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         286,350
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Total hours have been rounded.
\3\ We request revision of this information collection.
\4\ The burden estimate for this information collection is currently approved and included for the convenience
  of the reader. We do not request revision of this line item at this time.

                            Table 6--Estimated Annual Third-Party Disclosure Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    Activity; 21 CFR Section         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure        \2\
----------------------------------------------------------------------------------------------------------------
Technical and safety information               1               1               1              12              12
 for users--1002.3 \3\..........
Dealer/distributor records--                  30               3              90               1              90
 1002.40 and 1002.41 \3\........
Television receiver critical                   1               1               1               1               1
 component warning--
 1020.10(c)(4) \3\..............
Cold cathode tubes--                           1               1               1               1               1
 1020.20(c)(4) \3\..............
Report of assembly of diagnostic           1,230              34          41,820             0.3          12,546
 x-ray components--1020.30(d),                                                      (18 minutes)
 (d)(1)-(2) (Form FDA 2579--
 Assembler report) \4\..........
Information on diagnostic x-ray                6               1               6              55             330
 systems--1020.30(g) \3\........
Statement of maximum line                      6               1               6              10              60
 current of x-ray systems--
 1020.30(g)(2) \3\..............
Diagnostic x-ray system safety                 6               1               6             200           1,200
 and technical information--
 1020.30(h)(1)-(4) \3\..........
Fluoroscopic x-ray system safety               5               1               5              25             125
 and technical information--
 1020.30(h)(5)-(6) and
 1020.32(a)(1), (g), and (j)(4)
 \3\............................
CT equipment--1020.33(c)-(d),                  5               1               5             150             750
 (g)(4), and (j) \3\............
Cabinet x-ray systems                          6               1               6              40             240
 information--1020.40(c)(9)(i)-(
 ii) \3\........................
Microwave oven radiation safety                1               1               1              20              20
 instructions--1030.10(c)(4) \3\
Microwave oven safety                          1               1               1              20              20
 information and instructions--
 1030.10(c)(5)(i)-(iv) \3\......

Microwave oven warning labels--                1               1               1               1               1
 1030.10(c)(6)(iii) \3\.........
Laser products information--                   2               1               2              20              40
 1040.10(h)(1)(i)-(vi) \4\......
Laser product service                          2               1               2              20              40
 information--1040.10(h)(2)(i)-(
 ii) \4\........................
Medical laser product                          2               1               2              10              20
 instructions--1040.11(a)(2) \3\
Sunlamp products instructions--                1               1               1              10              10
 1040.20 \3\....................
Mercury vapor lamp labeling--                  1               1               1               1               1
 1040.30(c)(1)(ii) \3\..........
Mercury vapor lamp permanently                 1               1               1               1               1
 affixed labels--1040.30(c)(2)
 \3\............................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          15,508
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Total hours have been rounded.
\3\ The burden estimate for this information collection is currently approved and included for the convenience
  of the reader. We do not request revision of this line item at this time.
\4\ We request revision of this information collection.

    The proposed revised estimates were generated from discussions with
subject matter experts at FDA.
    FDA is proposing to revise the applicability of the recordkeeping
and reporting requirements for some products (Sec.  1002.1). We revised
the burden estimates for product reports, abbreviated reports, and
annual reports by reducing the number of respondents to reflect the
revised applicability of the recordkeeping and reporting requirements.
We also proposed to revised Form FDA 3646 ``Mercury Vapor Lamp Products
Radiation Safety Report'' (now listed under Abbreviated Reports
consistent with the revision of Sec.  1002.1) and removed the following
forms:
     Form FDA 3626, ``A Guide for the Submission of Initial
Reports on Diagnostic X-Ray Systems and Their Major Components''
     Form FDA 3627, ``Diagnostic X-Ray CT Products Radiation
Safety Report''
     Form FDA 3638, ``Guide for Filing Annual Reports for X-Ray
Components and Systems,''
     Form FDA 3644, ``Guide for Preparing Product Reports for
Ultrasonic Therapy Products''
     Form FDA 3645, ``Guidance for Preparing Annual Reports for
Ultrasonic Therapy Products,''
     Form FDA 3647, ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Mercury Vapor Lamps''
     Form FDA 3661, ``Guide for the Submission of an
Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette
Holders Intended for Diagnostic Use''
     Form FDA 3662, ``Guide for Submission of an Abbreviated
Radiation Safety Reports on Cephalometric Devices Intended for
Diagnostic Use''
    The proposed revised applicability of the recordkeeping and
reporting requirements for dealer/distributor records (see Sec. Sec.
1002.40 and 1002.41) may result in a small decrease in the number of
respondents. However, upon calculating and rounding the estimated
annual number of respondents, we have determined there is no change to
the current burden estimate for this information collection.
    FDA is eliminating requirements for manufacturers to report model
numbers of new models of a model family that do not involve changes in
radiation emission or requirements of a performance standard in
quarterly updates to their annual reporting (Sec.  1002.13(c)). We have
removed the burden estimate associated with Sec.  1002.13(c).
Generally, other subsections require specified product manufacturers to
submit annual reports to FDA which summarize certain manufacturing
records (Sec.  1002.13(a) and (b)). FDA is not amending these annual
report requirements.
    FDA is proposing to amend the timing for submission of reporting
requirements for AROs that are not associated with a death or serious
injury (Sec.  1002.20). The proposed amendment will allow manufacturers
of a radiation emitting electronic product to submit quarterly summary
reports of AROs that are not associated with a death or serious injury
and not required to be reported under the medical device reporting
regulations (Sec.  1002.20; part 803). FDA believes that amending the
regulations to allow summary reporting for AROs for electronic products
extends the approach of eliminating or reducing duplicative reporting
requirements beyond the medical device arena and promotes harmonization
between this reporting and the new voluntary malfunction summary
reporting for medical devices (see part 803; ``Medical Devices and
Device-Led Combination Products; Voluntary Malfunction Summary
Reporting Program for Manufacturers'' (83 FR 40973, August 17, 2018)).
    FDA is also proposing to amend the applications for variances
process (Sec.  1010.4(b)) to no longer require a manufacturer to submit
two additional copies with the original documents. While this amendment
would not generate any substantive change to the information
collection, respondents may realize a small monetary savings from the
usual and customary administrative expenses associated with the
preparation of the copies.
    FDA is proposing to amend the reports of assembly requirements for
major components of diagnostic x-ray systems to no longer require
assemblers who install certified components to submit a report of
assemblies, Form FDA 2579, to CDRH (Sec.  1020.30(d)(1)) (Ref. 22). FDA
also proposes to withdraw the language to require submission to ``the
Director'' in this subsection, but will still publish a PDF form online
for assemblers to download, complete, and provide to applicable States
and purchasers as required. We have moved the corresponding information
collection burden estimate from reporting to third-party disclosure
burden and revised Form FDA 2579.
    FDA is proposing to amend the laser products regulation to add an
exception to the applicability of the laser product performance
standards (see Sec. Sec.  1040.10 and 1040.11) to a manufacturer who
incorporates an unmodified laser product into another product when such
laser product is not intended for use as a component or replacement and
such laser product is certified by the

manufacturer of such laser product, subject to certain conditions
(Sec.  1040.10(a)). We have reduced the number of respondents in our
burden estimate to reflect the amendment.
    FDA is proposing to repeal the performance standards for ultrasonic
therapy products (Sec.  1050.10). We have removed the burden estimate
associated with Sec.  1050.10.
    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB (see ADDRESSES). All comments should be
identified with the title of the information collection.
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has
submitted the information collection provisions of this proposed rule
to OMB for review. These revisions will not be effective until FDA
obtains OMB approval. FDA will publish a notice concerning OMB approval
of these revisions in the Federal Register.

X. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in E.O. 13132. We have determined that this
proposed rule does not contain policies that have substantial direct
effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.
    We note that the current performance standards at Sec.  1040.10
issued under section 534 of the FD&C Act preempt the States from
establishing or continuing in effect any standard that is not identical
to the Federal standard pursuant to section 542 of the FD&C Act (21
U.S.C. 360ss). Those standards were issued before the E.O. We believe
this preemption is consistent with section 4(a) of the E.O. which
requires agencies to ``construe . . . a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
at section 542 of the FD&C Act that preempts the States from
establishing, or continuing in effect, any standard with respect to an
electronic product which is applicable to the same aspect of product
performance as a Federal standard prescribed pursuant to section 534 of
the FD&C Act and which is not identical to the Federal standard. (See
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Riegel v. Medtronic,
Inc., 552 U.S. 312 (2008)). Section 542 of the FD&C Act does allow
States to impose a more restrictive standard regarding emissions of
radiation from electronic products under certain circumstances.
    This proposed rule does not impose any new performance standard
requirements. This proposed rule prescribes more defined exceptions
from the applicability of Federal standards (under proposed amendments
to Sec.  1040.10(a)) and a reduction in Federal standards (through
repeal of Sec.  1050.10) pursuant to section 534 of the FD&C Act. To
the extent that the proposed rule, if finalized, removes or excludes
applicability of certain Federal standards, any State issued
performance standards are no longer preempted.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in E.O. 13175. We have tentatively determined that
the rule does not contain policies that would have a substantial direct
effect on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes.
The Agency solicits comments from tribal officials on any potential
impact on Indian Tribes from this proposed action.

XII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. They also can be purchased as a pdf or as
hard copy (or both together, at a discounted price) from NCRP
(www.ncrponline.org). FDA has verified the website addresses, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.

*1. E.O. 13771 (January 30, 2017), available at https://www.federalregister.gov/documents/2017/02/03/2017-02451/reducing-regulation-and-controlling-regulatory-costs.
*2. E.O. 13777 (February 24, 2017), available at https://www.federalregister.gov/documents/2017/03/01/2017-04107/enforcing-the-regulatory-reform-agenda.
*3. EPA, Interagency Working Group on Medical Radiation, Federal
Guidance Report No. 14. ``Radiation Protection Guidance for
Diagnostic and Interventional X-Ray Procedures,'' 2014, available at
https://www.epa.gov/sites/production/files/2015-05/documents/fgr14-2014.pdf.
4. NCRP, ``Radiation Protection in Dentistry,'' Report No. 145,
2003, available at https://ncrponline.org/publications/reports/ncrp-reports-145/.
*5. American Dental Association and FDA, ``Dental Radiographic
Examinations: Recommendations for Patient Selection and Limiting
Radiation Exposure,'' Revised: 2012, available at http://
www.ada.org/~/media/ADA/Member%20Center/FIles/
Dental_Radiographic_Examinations_2012.pdf.
*6. CRCPD, ``Part F-Medical Diagnostic and Interventional X-ray
Imaging and Systems,'' available at https://c.ymcdn.com/sites/www.crcpd.org/resource/resmgr/docs/SSRCRs/F_Part_2015.pdf.
*7. The American College of Radiology publishes and regularly
updates Practice Parameters, Technical Standards, and
Appropriateness Criteria[supreg], available at https://www.acr.org/Quality-Safety/Appropriateness-Criteria.
*8. Department of Health and Human Services, FDA, Charter for
Technical Electronic Product Radiation Safety Standards Committee,
available at https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/TechnicalElectronicProductRadiationSafetyStandardsCommittee/UCM537440.pdf.
*9. 2016 TEPRSSC Meeting, October 25-26, 2016, available at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/TechnicalElectronicProductRadiationSafetyStandardsCommittee/ucm526004.htm.
10. NCRP, Radiation Dose Management for Fluoroscopically-Guided
Interventional Procedures, Report No.168, 2010, available at https://ncrponline.org/publications/reports/ncrp-report-168/.
*11. ICRP, ``Radiological Protection in Medicine.'' Publication 105.
Ann ICRP. 2007;37(6): 1-63, available at http://www.icrp.org/publication.asp?id=ICRP%20Publication%20105.
12. NCRP, Reference levels and achievable doses in medical and
dental imaging: recommendations for the United States, Report No.
172, 2012, available at

https://ncrponline.org/publications/reports/ncrp-report-172/.
*13. FDA, CDRH Health, Initiative to Reduce Unnecessary Radiation
Exposure from Medical Imaging (2010), available at https://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm2007191.htm.
*14. FDA, Medical X-ray Imaging, available at https://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/default.htm.
*15. NCRP, ``Ionizing Radiation Exposure of the Population of the
United States,'' Report No. 160, 2009, available at https://ncrponline.org/publications/reports/ncrp-report-160-2/.
*16. ICRP, ``The 2007 Recommendations of the International
Commission on Radiological Protection. ICRP publication 103.'' Ann
ICRP. 2007;37(2-4): 1-332, available at http://www.icrp.org/publication.asp?id=ICRP%20Publication%20103.
*17. CRCPD, Suggested State Regulations for Control of Radiation,
available at https://www.crcpd.org/page/ssrcrs.
*18. Centers for Medicare & Medicaid Services, Accreditation of
Advanced Diagnostic Imaging Suppliers, available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Accreditation-of-Advanced-Diagnostic-Imaging-Suppliers.html.
*19. FDA, ``Laser Notice No. 42--Clarification of Compliance
Requirements for Certain Manufacturers Who Incorporate Certified
Class I Laser Products Into Their Products,'' December 18, 1989,
available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095307.pdf.
*20. FDA, ``Policy Clarification and Premarket Notification [510(k)]
Submissions for Ultrasonic Diathermy Devices; Final Guidance for
Industry and Food and Drug Administration Staff,'' available at
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM573663.pdf.
*21. FDA, Report of Assembly of Diagnostic X-ray System, Form FDA
2579, available at https://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107879.htm.
*22. FDA eSubmitter, available at https://www.fda.gov/forindustry/fdaesubmitter/default.htm.
*23. Preliminary Economic Analysis of Impacts: Radiological Health
Regulations; Amendments to Records and Reports for Radiation
Emitting Electronic Products; Amendments to Performance Standards
for Diagnostic X-ray, Laser and Ultrasonic Products, available at
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 1000

    Electronic products, Radiation protection, Reporting and
recordkeeping requirements, X-rays.

21 CFR Part 1002

    Electronic products, Radiation protection, Reporting and
recordkeeping requirements, X-rays.

21 CFR Part 1010

    Administrative practice and procedure, Electronic products,
Exports, Radiation protection.

21 CFR Part 1020

    Electronic products, Medical devices, Radiation protection,
Reporting and recordkeeping requirements, Television, X-rays.

21 CFR Part 1040

    Electronic products, Labeling, Lasers, Medical devices, Radiation
protection, Reporting and recordkeeping requirements.

21 CFR Part 1050

    Electronic products, Medical devices, Radiation protection.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, we propose
that 21 CFR parts 1000, 1002, 1010, 1020, 1040, and 1050 be amended as
follows:

PART 1000--GENERAL

0
1. The authority citation for part 1000 continues to read as follows:

    Authority:  21 U.S.C. 360hh-360ss.

Sec.  1000.3  [Amended]

0
2. Revise Sec.  1000.3 by removing paragraph (s) and redesignating
paragraphs (t) and (u) as paragraphs (s) and (t).

Subpart C--[Removed]

0
3. Remove subpart C, consisting of Sec. Sec.  1000.50, 1000.55, and
1000.60.

PART 1002--RECORDS AND REPORTS

0
4. The authority citation for part 1002 continues to read as follows:

    Authority:  21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371,
374.

0
5. Amend Sec.  1002.1 by revising table 1 to read as follows:

Sec.  1002.1   Applicability.

* * * * *
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TP01AP19.005

[GRAPHIC] [TIFF OMITTED] TP01AP19.006

[GRAPHIC] [TIFF OMITTED] TP01AP19.007

BILLING CODE 4164-01-C

Sec.  1002.2  [Removed]

0
6. Remove reserved Sec.  1002.2.

Sec.  1002.13  [Amended]

0
7. Amend Sec.  1002.13 by removing paragraph (c).
0
8. Revise Sec.  1002.20 to read as follows:

Sec.  1002.20  Reporting of accidental radiation occurrences.

    (a) Manufacturers of electronic products shall, where reasonable
grounds for suspecting that such an incident has occurred, report to
the Director, Center for Devices and Radiological Health, all
accidental radiation occurrences reported to or otherwise known to the
manufacturer and arising from the manufacturing, testing, or use of any
product introduced or intended to be introduced into commerce by such
manufacturer. Reasonable grounds include, but are not necessarily
limited to, professional, scientific, or medical facts or opinions
documented or otherwise, that conclude or lead to the conclusion that
such an incident has occurred.
    (b) Such reports shall be submitted electronically through Center
for Devices and Radiological Health eSubmitter or addressed to Food and
Drug Administration, Center for Devices and Radiological Health, ATTN:
Accidental Radiation Occurrence Reports, Document Mail Center, 10903
New Hampshire Ave., Bldg. 66, Rm. G609, Silver Spring, MD 20993-0002,
and the reports and their envelopes shall be distinctly marked ``Report
on 1002.20'' and shall contain all of the following information where
known to the manufacturer:
    (1) The nature of the accidental radiation occurrence;
    (2) The location at which the accidental radiation occurrence
occurred;
    (3) The manufacturer, type, and model number of the electronic
product or products involved;
    (4) The circumstances surrounding the accidental radiation
occurrence, including causes;
    (5) The number of persons involved, adversely affected, or exposed
during the accidental radiation occurrence, the nature and magnitude of
their exposure and/or injuries and, if requested by the Director,
Center for Devices and Radiological Health, the names of the persons
involved;
    (6) The actions, if any, which may have been taken by the
manufacturer, to control, correct, or eliminate the causes and to
prevent reoccurrence; and
    (7) Any other pertinent information with respect to the accidental
radiation occurrence.
    (c) If a manufacturer:
    (1) Is required to report to the Director under paragraph (a) of
this section and also is required to report under part 803 of this
chapter, the manufacturer shall report in accordance with part 803; or
    (2) Is required to report to the Director under paragraph (a) of
this section and is not required to report under part 803 of this
chapter, the manufacturer shall:
    (i) Immediately report incidents associated with a death or serious
injury in accordance with paragraphs (a) and (b) of this section; and
    (ii) Either immediately report incidents not associated with a
death or serious injury individually or compile such incidents for
submission in a quarterly summary report with tracking and trending
analysis of that data in accordance with paragraphs (a) and (b) of this
section. A manufacturer need not file a separate report under this
section if an incident involving an accidental radiation occurrence is
associated with a defect or noncompliance and is reported pursuant to
Sec.  1003.10 of this chapter.

PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

0
9. The authority citation for part 1010 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss,
371, 381.

0
10. Section 1010.4 is amended by revising paragraph (b) introductory
text to read as follows:

Sec.  1010.4   Variances.

* * * * *
    (b) Applications for variances. If you are submitting an
application for variances or for amendments or extensions thereof, you
must submit an original copy by mail to the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Applications for variance can also be submitted
electronically through the Regulations.gov website under Docket Number
FDA-2013-S-0610 as a new comment with an upload of the variance
application materials.
* * * * *

PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING
PRODUCTS

0
11. The authority citation for part 1020 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371,
381.

0
12. Section 1020.30 is amended by revising paragraph (d)(1) to read as
follows:

Sec.  1020.30   Diagnostic x-ray systems and their major components.

* * * * *
    (d) * * *
    (1) Reports of assembly. All assemblers who install certified
components shall file a report of assembly, except as specified in
paragraph (d)(2) of this section. The report will be construed as the
assembler's certification and identification under Sec. Sec.  1010.2
and 1010.3 of this chapter. The assembler shall affirm in the report
that the manufacturer's instructions were followed in the assembly or
that the certified components as assembled into the system meet all
applicable requirements of Sec. Sec.  1020.30 through 1020.33. All
assembler reports must be on a form prescribed by the Director, Center
for Devices and Radiological Health. Completed reports must be
submitted to the purchaser and, where applicable, to the State agency

responsible for radiation protection within 15 days following
completion of the assembly.
* * * * *

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

0
13. The authority citation for part 1040 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss,
371, 381.

0
14. Section 1040.10 is amended by revising paragraph (a) to read as
follows:

Sec.  1040.10   Laser products.

    (a) Applicability. The provisions of this section and Sec.
1040.11, are applicable to all laser products, except when:
    (1) Incorporation of an uncertified laser product intended to be
used as a component or replacement for an electronic product--The
provisions of this section and Sec.  1040.11 are not applicable to an
uncertified laser product that is incorporated into an electronic
product that is then certified by the manufacturer of such finished
electronic product in accordance with Sec.  1010.2 of this chapter,
when:
    (i) Such a laser product is either sold to a manufacturer of an
electronic product for use as a component (or replacement) in such
electronic product, or
    (ii) Sold by or for such a manufacturer of an electronic product
for use as a component (or replacement) in such electronic product,
provided that such laser product:
    (A) Is accompanied by a general warning notice that adequate
instructions for the safe installation of the laser product are
provided in servicing information available from the complete laser
product manufacturer under paragraph (h)(2)(ii) of this section, and
should be followed,
    (B) Is labeled with a statement that it is designated for use
solely as a component of such electronic product and therefore does not
comply with the appropriate requirements of this section and Sec.
1040.11 for complete laser products, and
    (C) Is not a removable laser system as described in paragraph
(c)(2) of this section; and
    (iii) The manufacturer of such a laser product, if manufactured
after August 20, 1986:
    (A) Registers, and provides a listing by type of such laser
products manufactured that includes the product name, model number and
laser medium or emitted wavelength(s), and the name and address of the
manufacturer. The manufacturer must submit the registration and listing
to the Director, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G609,
Silver Spring, MD 20993-0002. Alternatively, reports may be submitted
electronically through Center for Devices and Radiological Health
eSubmitter.
    (B) Maintains and allows access to any sales, shipping, or
distribution records that identify the purchaser of such a laser
product by name and address, the product by type, the number of units
sold, and the date of sale (shipment). These records shall be
maintained and made available as specified in Sec.  1002.31 of this
chapter.
    (2) Incorporation of a certified laser product into another
product--The provisions of this section and Sec.  1040.11 are
applicable to a manufacturer of a laser product and are not applicable
as specified to a manufacturer who incorporates such laser product
manufactured or assembled after August 1, 1976, into another product,
when:
    (i) The manufacturer of such incorporated laser product is not a
laser product intended for use as a component or replacement as
described in paragraphs (a)(1)(i) and (ii) of this section,
    (ii) The manufacturer of the incorporated laser product certifies
such a laser product under Sec.  1010.2 of this chapter,
    (iii) The incorporated laser product is not modified as defined in
paragraph (i) of this section,
    (iv) The incorporated laser product is installed in accordance with
the instructions for the incorporated laser product as provided by the
manufacturer of the incorporated laser product,
    (v) The manufacturer of the incorporating product provides with the
incorporating product the user information required under paragraph (h)
of this section,
    (vi) The labeling requirements of Sec. Sec.  1010.3 of this chapter
and 1040.10(g) for the incorporated laser product would be met when the
incorporated laser product is removed from the incorporating product,
    (vii) The labeling requirements of Sec.  1040.10(g) for the
incorporated laser product would be met in any service configuration of
the incorporated laser product, even when that incorporated laser
product could be serviced without removal from the incorporating
product, and
    (viii) The manufacturer of the incorporating product otherwise
meets the requirements under this subchapter applicable to distributors
of laser products (Sec. Sec.  1002.40 and 1002.41 of this chapter).
* * * * *

PART 1050--[REMOVED AND RESERVED]

0
15. Remove and reserve part 1050.

    Dated: March 19, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-05822 Filed 3-29-19; 8:45 am]
BILLING CODE 4164-01-P