PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ Office of Enforcement and Compliance Assurance 2. OMB control number b. G None a. 2060 0417 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NESHAP for Oil and Natural Gas Production ( 40 CFR Part 63, Subpart HH) ( Renewal)

8. Agency form number( s) ( If applicable) 1788.06 9. Keywords Clean Air Act, Environmental Protection, Air Pollution Control, NESHAP, Oil and Natural Gas Production 10. Abstract This rule applies to existing facilities and new facilities that are major sources of hazardous air pollutants ( HAP) and that process, upgrade, or store ( 1) hydrocarbon liquids ( with the exception of those facilities that exclusively handle black oil) to the point of custody transfer and ( 2) natural gas from the well up to and including the natural gas processing plant. Specifically exempted from this regulation are oil and natural gas production wells. Respondents are required to submit one time initial notifications, including reports of start of construction, actual start up dates, and performance tests. In addition, respondents must submit semiannual reports of excess emissions and continuous monitoring system performance. All records must be maintained for at least 5 years. This information is being collected to assure compliance with 40 CFR part 63, subpart HH.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 127,202 b. Total annual responses 942 1. Percentage of these responses collected electronically 10 % c. Total hours requested 175,907 d. Current OMB inventory 29,489 e. Difference 146,418 f. Explanation of difference 1. Program Change 2. Adjustment 146,418 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 20 b. Total annual costs ( O& M) 476 c. Total annualized cost requested 496 d. Current OMB inventory 567 e. Difference ( 71) f. Explanation of difference 1. Program change 2. Adjustment ( 71)

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. Application for benefits e. Program planning or management b. Program evaluation f. Research c. General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe) 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Dan Chadwick Phone: ( 202) 564 7054 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement. Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C. § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of:

"( i) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number." OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Proposed Rules]
[Pages 71415-71427]
[FR Doc No: 2016-25026]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 807

[Docket No. FDA-2016-N-2491]
RIN 0910-AG79

Electronic Submission of Labeling for Certain Home-Use Medical
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to
implement provisions of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) to require electronic submission of the device label and
package insert of certain home-use devices when these devices are
listed with FDA. FDA plans to make this device labeling available to
the public through the Internet and would also provide search tools to
facilitate locating information concerning a particular home-use device
or a particular type of home-use device.

DATES: Submit either electronic or written comments on the proposed
rule by January 17, 2017. In accordance with 21 CFR 10.40(c), in
finalizing this rulemaking FDA will review and consider all comments
submitted before the time for comment on this proposed regulation has
expired.
    Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 by November 16, 2016; see section VI,
the ``Information Collection Requirements'' section of this document.
See section VIII of this document for the proposed effective date of a
final rule based on this proposed rule.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-2491 for ``Electronic Submission of Labeling for Certain
Home-Use Medical Devices.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management 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 http://www.regulations.gov. Submit both copies to the
Division of Dockets Management. 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: http://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 http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues to the Office of
Management and Budget in the following ways:
     Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>, or email to
<EMAIL_ADDRESS>All comments should be identified with the
title, ``Medical Devices: Submission of Home-Use Device Labels and
Package Inserts to FDA''.

FOR FURTHER INFORMATION CONTACT: Antoinette (Tosia) Hazlett, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993, 301-
796-6119, email<EMAIL_ADDRESS>    With regard to the information collection: FDA PRA Staff, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Introduction
    B. Public Health Benefits
    C. Overview of the Proposed Rule
    D. Public Participation in Setting the Scope and Objectives of
the Proposed Rule
III. Description of the Proposed Rule
    A. Scope of the Proposed Rule
    1. What devices would be subject to the proposed rule?
    2. When would a home-use device label and package insert be
submitted to FDA?
    3. Would every type of package insert regarding a home-use
device have to be submitted to FDA?
    4. Would the rule provide for the submission of advertisements
or of labeling other than device labels and package inserts?
    5. Would the rule require any change to an existing label or an
existing package insert?
    B. Submission of Device Labels and Package Inserts to FDA for
Certain Home-Use Devices
    1. Who would be required to submit labels and package inserts to
FDA when listing a home-use device?
    2. How would labels and package inserts be submitted to FDA?
    3. What would be the consequences of failing to submit the
listing information identified in this proposed rule?
    C. Dissemination of the Information Collected Under the Rule
    1. How does FDA intend to make available the information
collected under the rule?
    2. How will members of the public be able to find information
collected under this rule and related FDA information concerning a
home-use device?
    D. Proposed Amendments to Part 807
    1. New Defined Terms
    2. Conforming Amendment of Sec.  807.26(e)
    3. Proposed Requirement To Submit the Label and Package Insert
of Certain Home-Use Devices
    E. Effective Date
IV. Legal Authority
V. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
    C. Summary of Regulatory Flexibility Analysis
VI. Information Collection Requirements
VII. Analysis of Environmental Impact
VIII. Proposed Effective Date
IX. Federalism
X. References

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to require certain medical device establishments
listing devices under section 510(j) of the FD&C Act (21 U.S.C.
360(j)), if the device is labeled for home use, to submit the device
label and package insert of such listed medical device, in the
electronic format mandated in the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), when the device is
listed with FDA. (See section 510(p) of the FD&C Act.) FDA plans to
make this device labeling information available to the public through
an FDA-managed or partner Internet Web site.

B. Summary of the Major Provisions of the Proposed Rule

    The electronic submission requirements of the proposed rule would
be limited to only devices labeled for home use that are regulated by
the Center for Devices and Radiological Health (CDRH) as class II and
class III devices. For purposes of the proposed rule, a ``home-use
device'' is any medical device that is labeled for use outside a
professional health care facility. Sampling information indicates that
this device group has a higher risk of misuse due to lost or misplaced
labeling and operating instructions. In addition, the proposed rule
would allow the voluntary electronic submission of device labels and
package inserts for any class I home-use device or other home-use
device not subject to the electronic submission requirements of the
rule.

C. Legal Authority

    FDA is issuing the provisions of this proposed rule that would
implement the listing requirement for the submission of labels and
package inserts for home-use medical devices under section 510(j) and
section 701(a) (21 U.S.C. 371(a)) of the FD&C Act, which provides FDA
the authority to issue regulations for the efficient enforcement of the
FD&C Act. Section 510(p) of the FD&C Act requires that registrations
and listings under section 510 be submitted to the Secretary by
electronic means unless the Secretary grants a request for waiver
because the use of electronic means is not reasonable for the person
requesting such waiver.

D. Costs and Benefits

    FDA will use the existing FDA's Unified Registration and Listing
System (FURLS) database and software systems to receive the submitted
electronic labeling information and will bear the incremental cost of
launching and maintaining the FDA-managed or partner Web site to
display and make the submitted information available for the public to
search and retrieve. The

benefits of this proposed rule would stem from a reduced incidence of
adverse events due to the increased availability of medical device
labeling. We estimate that the present discounted value number of
people most likely to benefit from this rule over 10 years is 66.9
million, using a 7 percent discount rate, or 80.1 million, using a 3
percent discount rate. We estimate that the present discounted value of
costs over 10 years would range from $48.5 to $51.7 million at a 7
percent discount rate and from $52.5 to $56.5 million at a 3 percent
discount rate.

II. Background

A. Introduction

    The Medical Device Amendments of 1976 amended section 510(j) of the
FD&C Act to add requirements for registration of device establishments
and listing of medical devices. Section 510(j) requires that every
person who registers shall list all devices manufactured, prepared,
propagated, compounded, or processed by him for commercial
distribution. The statute provides that, for all devices subject to the
listing requirement, the list must be accompanied by copies of the
device label and, as defined in this proposed rule, the package insert.
(See section 510(j)(1)(B)(ii) of the FD&C Act.) Our definition of
``package insert'' in this proposed rule would apply only to proposed
subpart F. The statute also provides additional listing requirements
for the submission of labeling and advertising for certain categories
of devices (see section 510(j)(1)(A) and 510(j)(1)(B)(i) of the FD&C
Act), which are not relevant to this proposed rulemaking.
    When section 510(j) was added to the FD&C Act in 1976, and for many
years thereafter, medical device registration and listing required the
submission of paper forms to FDA. The forms had to be manually
transcribed by FDA into its data systems, and the data stored primarily
on reels of magnetic tape and floppy disks. There was no practical way
for FDA to compile, update, or access the information submitted on
these forms, much less provide routine public access to the
information.
    Taking these factors into consideration, when FDA proposed
regulations regarding the device listing requirements, we explained
that, instead of requiring the submission of ``information that FDA may
not have immediate need for, and unless constantly updated by the owner
or operator, would be out of date when needed,'' FDA by regulation
would require that the owner or operator maintain a historical file of
labels, labeling, and for restricted devices, advertisements, and make
all or part of that file available to FDA upon request. (See 42 FR
52808 at 52809 (September 30, 1977).) That approach has remained in
place since the final rule was issued in 1978 (43 FR 37990 (August 25,
1978)). The regulation made clear that FDA could require the submission
of device labeling upon request by letter. Id.
    In 2002, Congress recognized the technological and practical impact
of the Internet when it passed the Medical Device User Fee and
Modernization Act (MDUFMA) (Pub. L. 107-250). Section 206 of MDUFMA
amended section 502(f) of the FD&C Act (21 U.S.C. 352(f)) to authorize
electronic labeling for a device intended for use in health care
facilities, provided the manufacturer afforded health care facilities
the opportunity to request the labeling in paper form without
additional cost. Section 207 of MDUFMA added section 510(p) to the FD&C
Act, giving FDA the authority to collect registrations and listings
``by electronic means'' at such time as FDA determined it was feasible
to receive such information through electronic means. In doing so,
Congress observed the following:

    The Internet and increased computer usage have created a
preference in many users for information for use applicable to
prescription devices in electronic form. Even casual users of
computers have become used to receiving electronic information . . .
. The [legislation] conforms FDA practice to the norm by allowing
manufacturers to provide healthcare facilities (such as hospitals,
doctors' offices and clinics) labeling in this alternative medium .
. . . This will better allow manufacturers to provide such
facilities with information that is more robust, up-to-date, and
user-friendly. . . Given the increased reliance on computer usage,
[MDUFMA section 207] requires manufacturers to provide registration
information required under section 510 by electronic means . . .
upon a finding by [FDA] . . . that electronic receipt of such
information is feasible. . . .\1\

    \1\ H.R. Report. No. 107-728, at 41, 107th Cong., 2d Sess.
(2002) (explaining MDUFMA sections 206 and 207).
---------------------------------------------------------------------------

    Subsequently, section 224 of FDAAA struck the language that
required FDA to make a finding that receipt of electronic submissions
``is feasible'' and instead made the submission of registration and
listing information by electronic means mandatory in all instances,
except where FDA grants a request for waiver of the requirement for a
person for whom electronic submission ``is not reasonable.'' (See
section 510(p) of the FD&C Act.)
    This preamble explains how FDA is proposing to further implement
sections 510(j) and 510(p) of the FD&C Act, by amending FDA's listing
regulations to require the submission of electronic versions of the
label and package insert for certain home-use medical devices when
these devices are listed with FDA. For purposes of this proposed rule,
the term ``home-use device'' would mean a medical device labeled for
use in any environment outside a professional health care facility.
    A ``professional health care facility'' is either (1) any
environment where personnel with medical training are continually
available to oversee or administer the use of medical devices,
including, but not limited to, hospitals, long-term care facilities,
nursing homes, emergency medical services, clinics, physicians'
offices, and outpatient treatment facilities; or (2) a clinical
laboratory. A ``clinical laboratory'' is a facility that (1) performs
testing on materials derived from the human body for the purpose of
providing information for the diagnosis, prevention, or treatment of
any disease or impairment of, or assessment of the health of, human
beings; and (2) has been certified to perform such testing under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C.
263a) in accordance with 42 CFR part 493, or is CLIA-exempt. These
definitions of ``professional health care facility'' and ``clinical
laboratory'' are only meant to provide guidance as to the application
of proposed subpart F and are not meant for any other purpose,
including the application of 42 U.S.C. 263a and 42 CFR part 493.
    FDA is proposing that the home-use devices that would be subject to
this proposed rule, if finalized, are those that are regulated by CDRH
as class II or class III devices. This proposed rule would not apply to
any class I devices, nor would it apply to devices regulated by the
Center for Biologics Evaluation and Research (CBER), except to allow
the voluntary submission of a device's label and package insert for
such home-use devices under proposed Sec.  807.220(a) (21 CFR
807.220(a)).
    This proposed rule is intended to focus on higher-risk home-use
devices. Under the FDA device classification system, the Agency
classifies a device into a particular class based on the level of
control necessary to provide a reasonable assurance of its safety and
effectiveness, with class I requiring the least amount of control and
class III requiring the most. (See sections 513(a)(1)(B) and
513(a)(1)(C)(i)(I) of the FD&C Act (21 U.S.C. 360c(a)(1)(B) and 360c
(a)(1)(C)(i)(I)).) The proposed rule

focuses on class II and class III devices, which are considered
moderate- to high-risk devices, and, except for permitted voluntary
submissions, does not implicate class I home-use devices. By limiting
implementation to these home-use devices, the proposed rule would focus
on those types of home-use devices where patients, caregivers, and
health care professionals have a significant need for quick and easy
access to information to help ensure a device can be used safely to
achieve its intended health benefits. Further, limiting the scope of
the proposed rule to a small subset of important home-use devices will
allow FDA to gain experience with the receipt, archiving, and
dissemination to the public of electronic versions of device labels and
package inserts before we consider any broader implementation, which
should create efficiencies with regard to Agency resources.

B. Public Health Benefits

    Home-use devices have significant public health importance to
patients, caregivers, and health care professionals. But when used in
an environment where a health care professional is not available to
provide supervision and assistance, the Agency recognizes that these
devices can present unique concerns and challenges (Ref. 1). In this
preamble, we use the term ``patient'' to refer to any health care
recipient, including someone who is not receiving care from a health
care professional, e.g., a person with a chronic condition who self-
administers a treatment, or a person who receives care from a family
member or friend. We use the term ``caregiver'' to refer to a person
who provides voluntary help or care, e.g., a family member, friend,
neighbor, or acquaintance, and we use ``health care professional'' to
refer to someone whose profession is in the health care sector, e.g., a
physician or a visiting nurse who provides care in the course of his or
her duties. Because our use of these terms corresponds to their
ordinary (plain language) meanings, we are not proposing regulatory
definitions. In discussing patient labeling considerations for medical
devices in general, we used similar terminology in ``Guidance on
Medical Device Patient Labeling: Final Guidance for Industry and FDA
Reviewers'' (Ref. 2).
    Medical devices are different from other FDA-regulated medical
products--e.g., drugs and biologics--in that many devices are commonly
intended to be used for many years and often do not have explicit
expiration or recommended ``use-by'' dates. When a home-use device is
used over a period of years, it becomes increasingly more likely that
it may be separated from its original labeling or that its original
labeling will not include current safety information or instructions
for use. Additionally, home-use devices are much more likely to be used
by lay users, who frequently have not been trained to use such medical
devices and who are especially reliant on the instructions for use and
other information provided by the device label and package insert. In
contrast with use in professional health care settings, a patient or
caregiver using a home-use device in a setting without professional
oversight may not have extensive experience in the use of a device and
may not have ready access to the original packaging or to alternative
sources of information about a device.
    Those people that use home-use devices are particularly vulnerable
to adverse events because they may be inexperienced in the proper use
and maintenance of the devices. In 2014, there were over 800,000
adverse events associated with medical devices. Our review of adverse
reports that meet the criteria for faster level of review (Code Blue
reports of deaths, fires, explosions, etc.) found, on average, three to
five such reported events per week as having occurred in the home
environment, i.e., outside of a clinical facility. The Agency believes
that device labeling information that would be submitted under this
proposed rule and made readily accessible on an FDA-managed or partner
Web site could reduce the incidence of adverse events when the labeling
is lost or misplaced and the user is inexperienced with the home-use
device, or when the labeling of the device has been updated with new
information.
    When a home-use device becomes separated from its labeling--and the
user no longer has ready access to the important information provided
in those materials, such as indications for use, contraindications,
warnings, precautions, and instructions for setup, use, and maintenance
of the device--the device user may be faced with serious obstacles to
the safe and effective use of the device (Ref. 3). The absence of such
critical information may lead to the device being used incorrectly,
which could result in the delay of proper treatment or even injury to
the patient. Improper use of a device can expose both the patient and
caregiver to potentially serious risks--risks that could be avoided if
information presented in the device's labeling was readily available.
In addition, health care professionals, including emergency personnel
who need to gain a rapid understanding of the operation and limitations
of a device, may be left unsure as to how to best respond to a critical
situation.
    When the labeling that describes how to operate a device is
missing, there is a higher chance that a device might be misused. CDRH
has received reports of unavailable labeling for devices that could be
dangerous when used by patients or caregivers outside a professional
health care facility. For example, missing labeling for something as
simple as a patient lift is dangerous when an elderly caregiver needs
to understand how to assemble and safely operate the lift. Another
example is a patient on home hemodialysis who needs to refer to
available labeling for proper warnings and precautions, water type, or
filters needed.
    Although many manufacturers have Internet sites that provide
information concerning the devices they currently market, those sites
typically focus on newer products and often do not provide any
information on devices that they no longer actively market. Sites also
vary considerably in the types of information provided and may lack
important details concerning their devices. Although some
manufacturers' Web sites provide some labeling, FDA believes that most
do not provide the label and package insert for all of their home-use
devices listed with FDA.
    The proposed rule would help to address these concerns by making it
possible for FDA to establish an electronic database, published online
and accessible to the public through the Internet, of labels and
package inserts for listed home-use devices that would be submitted
under this proposed rule. This database would fill an important gap in
the information available to patients, caregivers, and the health care
community concerning these home-use devices, and would allow both broad
searches to identify legally marketed home-use devices that may fill a
particular need and focused searches to obtain information concerning
the use of a specific home-use device. In recent years, patients have
become more involved in decisions concerning their health care,
including the types of treatments they will undergo, the selection of
specific home-use devices to be used in their treatment, and
administration of the course of treatment (Ref. 4). This trend shows no
signs of abating. With less day-to-day oversight by health care
professionals, consumers have assumed responsibilities that have been
traditionally borne by health care professionals. For example,
consumers

may take on responsibility for setting up a home-use device, monitoring
its performance, performing basic maintenance, and more. Because of
this expanding role, consumers need to understand the risks and
benefits of particular home-use devices in order to make informed
decisions concerning their treatment options, and need ready access to
information that will help them use devices properly, as intended by
the manufacturers.
    The FDA-managed or partner Internet Web site would provide a
consolidated and easily accessible source of FDA database information
concerning class II and class III home-use devices, including their
approval or clearance status, intended uses, limitations, setup, and
operation. The FDA database would not contain identifiable private
information nor provide access to ``lock out'' information that is not
included on the device labeling but is furnished through a source
referenced in the device labeling, e.g., information contained on a
manufacturer's Web site, access to which is limited to professionals or
some other restricted class of users. The FDA-managed or partner
Internet site would contain links to other FDA information concerning
the device, such as premarket submission information (e.g., the summary
of safety and effectiveness for a device), adverse event reports,
alerts and notices, and recalls, as well as FDA information concerning
the manufacturer. The information provided by FDA would help ensure
greater safety and effectiveness of class II and class III home-use
devices, particularly when a device has become separated from its
labeling or when health care professionals, including visiting home
nurses and emergency rescue personnel with varied skills and
experience, need rapid access to information about unfamiliar products
to help resolve a medical emergency. FDA would be able to make such
information available from the time the device is first listed and,
because the use of a device can continue long after a manufacturer
ceases to market the specific device, we would continue to provide
information even after the device is no longer marketed and no longer
listed. FDA expects to provide search tools to facilitate locating
information concerning a particular device or a particular type of
device.
    FDA also intends to make available the information collected under
this rule through other partner Web sites that provide medical and
health information to the public. For example, ``Daily Med'' (http://dailymed.nlm.nih.gov) is an Internet site administered by the National
Institutes of Health's National Library of Medicine (NLM) that provides
access to the labels and package inserts of prescription drugs. FDA
believes that the public access to the labels and package inserts of
the home-use medical devices covered by this proposed rule would
provide a benefit similar to that provided by Daily Med in the drugs
context.

C. Overview of the Proposed Rule

    The proposed rule, if finalized, would implement provisions of
sections 510(j)(1)(B)(ii) and 510(p) of the FD&C Act by amending FDA's
listing regulations to provide that the label and package insert must
be submitted electronically to FURLS, as part of the information
required to list any home-use device regulated by CDRH as a class II or
class III device. Section 510(j) requires manufacturers to list their
medical devices and outlines the types of information that must
accompany each listing. However, this proposed rule would apply only to
class II and class III home-use devices regulated by CDRH, which
represents a subset of devices that are subject to section 510(j) of
the FD&C Act. For class II and class III home-use devices, the rule
would amend the device listing regulations to provide that
establishments listing such devices must submit to FDA a copy of the
label and package insert of such home-use devices, when they are listed
with FDA by electronic means, in an electronic format that we will
specify and not as printed (paper) copies.
    Unless a request for waiver is granted, all of the information
submitted to FDA under the proposed rule would have to be submitted by
electronic means, as required by section 510(p) of the FD&C Act, in a
format to be specified by FDA that we can process, review, and archive.
Initially, we intend to allow for the submission of labels and package
inserts saved in Portable Document Format (PDF). The PDF format is a
broadly used format that preserves both the content and appearance of a
source document (such as a device label or package insert) and which
can be read on all mainstream personal computers, regardless of the
operating system, using freely available software. In addition, a wide
variety of software packages and operating systems allow a source
document to be saved as a PDF file. FDA believes that all listing
establishments are already familiar with the PDF format, and that most
already have the ability to save source documents as PDF files. We
intend to make available additional information that will provide
details and recommendations regarding this process by the time we
publish a final rule.
    At a later time, we expect to provide processes for the submission
of labels and package inserts based on FDA's Structured Product
Labeling (SPL) document standard. This would make it easier for FDA and
the public to store, retrieve, and search information in home-use
device labels and package inserts. We are considering at least two such
processes--one process that would make it easy for a small business
with limited means to submit SPL information by manually entering or
uploading the information for one product at a time on an FDA Web page
(this type of process is often referred to as a ``data entry''
process), and a second process that would provide an efficient way to
submit SPL data for multiple devices in a single submission (this type
of submission process is often referred to as a ``batch submission''
process). We intend to provide information explaining each process as
it becomes available.
    FDA plans to retain all labels and package inserts submitted under
this rule in FDA's FURLS database. Not all information in the FURLS
database is available to the public, so we intend to make the submitted
labeling accessible to the public through an FDA-managed or partner
Internet Web site, such as NLM, even after a device is no longer
listed. However, if FDA bans a device under section 516 of the FD&C Act
(21 U.S.C. 360f), we intend to remove any label and package insert from
our FURLS database and from any other FDA or partner Web site we might
use and replace those materials with a statement explaining that the
device has been banned. If a device is recalled, we may add a notice to
the labeling database, with additional information to help ensure the
safe and effective use of the device, or advice to discontinue use of
the device and additional steps to take to help ensure the health and
safety of the patient or user of the device.

D. Public Participation in Setting the Scope and Objectives of the
Proposed Rule

    FDA used comments from the medical device industry, health care
professionals, caregivers, and patients to help formulate the
objectives and define the scope of this proposed rule. In September
2009, CDRH established the ``510(k) Working Group'' and the ``Task
Force on the Utilization of Science in Regulatory Decision Making'' to
address concerns about how well the 510(k) program (the primary
regulatory route to market for medical devices) was meeting its public
health goals of

facilitating innovation and assuring the safety and effectiveness of
medical devices. As part of these reviews, FDA held two public meetings
and three town hall meetings, solicited comments through three open
public dockets, and met with many stakeholders over several months. In
August 2010, CDRH released for public comment preliminary reports from
these committees. The preliminary reports expressed concern regarding
the lack of ready access to final device labeling and recommended:
     FDA should ``take steps to improve medical device
labeling, and to develop an online labeling repository to allow the
public to easily access this information.'' (Ref. 5)
     FDA should ``revise existing regulations to clarify the
statutory listing requirements for the submission of labeling.'' (Ref.
6)
     FDA should ``explore the feasibility of requiring
manufacturers to electronically submit final device labeling to FDA . .
. and also to provide regular, periodic updates to device labeling,
potentially as part of annual registration and listing or through
another structured electronic collection mechanism.'' (Ref. 6)
    The preliminary reports also recommended that if FDA requires
submission of device labels, they be ``posted as promptly as feasible
on the Center's public 510(k) database.'' (Ref. 6)
    FDA received comments on these recommendations from industry,
consumer, and health care professional groups. Some industry
representatives expressed concern regarding the potential for
disclosure of confidential or proprietary information. According to
some industry representatives, device-specific information on device
labels is not necessarily appropriate for the general public, but
rather is intended for physicians or other health care professionals
and may cause confusion if they are made available in a public
database. Furthermore, industry suggested that the responsibility for
disseminating labeling should rest solely with the manufacturer and
should remain in the manufacturer's control. Industry also stated that
many updates to labeling are made for marketing purposes and not
related to regulatory requirements or device alterations.
    Consumer and health care professional groups supported the
recommendation of the 2010 510(k) Working Group and the Task Force
preliminary reports. Their comments noted that providing access to
online labeling resources would facilitate better-informed clinical
decisionmaking.
    In January 2011, FDA issued a ``Plan of Action'' outlining steps we
will take to improve the 510(k) program and explaining our views and
responses to comments we received concerning recommendations made in
the August 2010 preliminary reports (Ref. 7). FDA agreed with comments
that making labeling readily available could lead to better-informed
clinical decisionmaking. Just as the FDA's central database for drug
labeling conveys a public health benefit, we believe that a similar
database for devices would be of significant benefit to the public
health by providing useful information to health care professionals and
patients. Although submission of labels and certain other labeling for
all devices is a statutory requirement, FDA determined that it was
important to seek additional stakeholder input at a public meeting
before proposing any regulatory changes.
    FDA held another public meeting in April 2011, specifically to
discuss options, benefits, costs, and concerns regarding the collection
of device labels and certain labeling and means of making the resulting
information available to the public, including industry, health care
professionals, caregivers, and patients (Ref. 8). Industry
representatives did not support a system that would require submission
of labels and other labeling for all devices to FDA, but generally
agreed that there would be value in a more limited system, particularly
with regard to devices intended for home use. Health care professionals
and caregiver representatives were supportive of a broad system, but
willing to consider any approach that would increase their access to
reliable device information.
    Reports by FDA's committees recommended that FDA fully implement
section 510(j) by developing an electronic submission method for labels
and package inserts for devices generally and many stakeholders
supported the creation of a broad ``repository'' (essentially, an FDA-
managed database accessible to the public through an Internet site) of
labeling for all devices. However, FDA believes, at this stage, that
the public health need for, and the opportunity to improve access to
home-use device information call initially for the more-limited actions
pursued in this proposed rule. In order to minimize risks and costs
while we gain experience with implementing and managing electronic
labeling, the Agency is limiting this proposed rule to only include the
submission of labels and package inserts from home-use devices
regulated by CDRH as class II or class III devices. As FDA and the
public gain experience with the electronic submission of labeling and
use of the planned searchable FDA-managed or partner Internet Web site,
FDA will consider whether to implement this requirement for other
categories of devices, or for devices generally.
    FDA also conducted a series of followup focus group interviews of
health care professionals to obtain their individual views concerning a
wide variety of topics relating to medical device labeling, resulting
in a series of reports, including ``Medical Device Labeling for Health
Care Practitioners: Focus Group Study'' (May 2011) (Ref. 9) and
``Device Labeling Study: Practitioner Perspectives on Utility, Format,
and Content of an Abbreviated Version of Labeling'' (March 2013) (Ref.
10). Participants saw considerable value in having device labeling
available online for quick access when needed; participants noted that
labeling that is not directly placed on a device--for example, a
manual--can be hard to find when needed. Unlike a device label or
package insert, information made available through the Internet is
always readily available and cannot be lost or misplaced. Most
participants favored having access to labeling through an Internet Web
site, particularly if well-organized.
    Additionally, in September 2015, FDA held a public meeting to
discuss issues associated with medical device patient labeling that
involved development, use, and access to device information (Ref. 11).
At this meeting, many external stakeholders stated their belief that
providing labeling in one place for consumers that is reliable and
dynamic would increase accessibility to labeling for legacy devices and
to labeling updates as new information becomes available for currently
marketed devices. Also, while device information from other sources
such as Web sites and YouTube videos may be useful, stakeholders
indicated concern that some may be potentially erroneous and contain
mostly promotional information.

III. Description of the Proposed Rule

A. Scope of the Proposed Rule

1. What devices would be subject to the proposed rule?
    A device would be subject to the proposed rule if it is a ``home-
use device'' as defined by proposed Sec.  807.200, that is regulated by
CDRH as a class II or class III medical device. Under this proposed
regulation, a

``home-use device'' would be any medical device that is labeled for use
outside a professional health care facility. Home-use devices that are
co-labeled for, or can be used in a professional health care facility,
would be subject to this proposed rule if the device is labeled for use
in a patient's home or in any other environment that is not a
professional health care facility.
    Class I devices and devices regulated by CBER are not within the
scope of the proposed rule, except for the authorized voluntary
submission of a device's label and package insert for these home-use
devices (under proposed Sec.  807.220(a)). For more information about
the definition of ``home-use device,'' please refer to section III.D.1
of this document.
2. When would a home-use device label and package insert have to be
submitted to FDA?
    Proposed Sec.  807.205 would require the label and package insert
of a home-use device subject to the proposed rule to be submitted
whenever any provision within part 807 (21 CFR part 807) requires
listing information to be submitted or updated. For example, the label
and package insert would be required with such home-use device's
initial listing required by Sec.  807.22(a), with each annual listing
under Sec.  807.22(b), and whenever an action triggers a reporting
requirement under Sec.  807.28. If the label and package insert have
already been submitted and have not been changed since they were last
submitted to FDA, the establishment may simply certify that no change
has been made to the previously submitted labeling; see proposed Sec.
807.300(a). An updated label or package insert could be submitted
voluntarily at any time; see proposed Sec.  807.300(b).
3. Would every type of package insert regarding a home-use device have
to be submitted to FDA?
    No. The rule would limit the definition of ``package insert'' to
include only those informational materials directed to the intended
user of the device, and which are provided in a device package or which
accompany the device when it is delivered to the user, including when
already provided by electronic means. (See the proposed definition of
package insert at Sec.  807.200.) Only package inserts meeting this
definition would have to be submitted to FDA. We have chosen to limit
the scope of package insert in order to focus the proposed rule on
those package inserts that are essential to typical intended uses and
typical users of the home-use devices subject to this proposed rule.
Examples of materials that would not be within the scope of the
proposed rule include materials that are not intended for a patient
(care recipient) or for the caregiver, health care professional, or
family member who directly operates or handles the device or provides
assistance to the patient in using the device, e.g., an installation
and calibration manual intended for technical or support personnel;
supplemental training materials; supplemental service manuals;
supplemental materials that concern optional additional uses that
require accessories not included with the listed home-use device; and
any supplemental materials that are made available only upon request or
only upon payment of a separate fee.
4. Would the rule provide for the submission of advertisements or of
labeling other than device labels and package inserts?
    No. The proposed rule would not address the submission of
advertisements or of labeling other than the device label and package
insert.
5. Would the rule require any change to an existing label or package
insert?
    No. The proposed rule would not affect the form or content of home-
use device labeling. Existing labeling requirements would continue to
apply, including those of part 801 (Labeling) and Sec.  809.10
(Labeling for in vitro diagnostic products.).

B. Submission of Device Labels and Package Inserts to FDA for Certain
Home-Use Devices

1. Who would be required to submit labels and package inserts to FDA
when listing a home-use device?
    The owner or operator of an establishment (the remainder of this
preamble will simply refer to ``the establishment'') that lists a class
II or class III home-use device subject to this proposed rule would be
responsible for submission of the label and package insert, just as the
establishment is responsible for submitting all other listing
information pertaining to the device. (See proposed Sec.  807.205.)
2. How would labels and package inserts have to be submitted to FDA?
    The proposed rule provides for the electronic submission of this
information to FDA, as required by section 510(p) of the FD&C Act, in a
form specified by FDA that we can process, review, and archive; see
proposed Sec.  807.205. Initially, FDA expects to specify saving the
device label and package insert as PDF files and submitting those
materials to FDA. Later, we expect to transition from submission of
PDFs to submission of SPL-formatted information. We intend to publish
information describing the entire proposed process by the time we
publish a final rule. If a waiver from filing registration and listing
information electronically has been obtained under Sec.  807.21(b), the
establishment would be required to submit the device labels and package
insert called for in this proposed rule in the same manner as permitted
for other registration and listing information covered by the waiver,
as directed by Sec.  807.34.
    When the proposed rule is finalized, an establishment submitting a
home-use device's label and package insert would confirm or provide the
FDA-assigned premarket submission number of the device (Sec.
807.25(g)(4)) or the product codes for 510(k)-exempt devices (Sec.
807.25(g)(2)).
3. What would the consequences be of failing to submit the listing
information identified in this proposed rule?
    The failure to provide information required by section 510(j) of
the FD&C Act, as implemented by part 807, including proposed subpart F,
causes a device to be misbranded under section 502(o) of the FD&C Act
and is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C.
331(p)), which may result in seizure, injunction, or other penalties.

C. Dissemination of the Information Collected Under the Rule

1. How does FDA intend to make available the information collected
under this rule?
    FDA intends to make the labels and package inserts collected under
this rule available on an FDA-managed or partner Internet Web site. We
intend to link the labels and package inserts submitted under this rule
to the listing record for the particular device. Over time, and as
resources permit, we also intend to link each device listing to other
FDA information, such as the device identifier required by FDA's unique
device identification system, FDA premarket submission numbers, adverse
event reports, and public health notifications, so that users of the
planned FDA-managed or partner Internet Web site will also be able to
access public information that is maintained in FDA's other databases
concerning devices marketed or manufactured in the United States.

2. How will members of the public be able to find information collected
under this rule and related FDA information concerning a home-use
device?
    We intend to provide several ways to search for information, such
as the ability to search by:
     Proprietary name (for a specific device);
     Product code (for a generic type of device);
     Firm name (for all devices listed by a particular firm);
     FDA premarket submission number;
     Device identifier (the static portion of the unique device
identifier required by Sec. Sec.  801.20 and 801.40).
    We also intend to provide a means to search the full text of labels
and package inserts using free-form searches.

D. Proposed Amendments to Part 807

1. New Defined Terms
    FDA is proposing to add definitions for two terms to part 807;
these terms have not been defined in any prior medical device
regulation: Home-use device and package insert.
    Home-use device would mean a medical device that is labeled for use
in any environment outside a professional health care facility. This
definition is meant to make clear that ``home-use device,'' as defined
in this proposed rule, would not be restricted in a literal sense to
use in a patient's home, but is instead meant to take in a broader
range of environments in which a device may be used outside of a
professional health care facility.
    If finalized, the definition of home-use device is meant to apply
only to proposed subpart F for purposes of submitting the device's
label and package insert when listing under section 510(j) of the FD&C
Act. This proposed regulation would not apply for other purposes,
including premarket submission determinations. Additionally, proposed
Sec.  807.200 would not apply for purposes of CLIA categorization under
42 CFR 493.15. The fact that a device would be considered a ``home-use
device'' under this proposed regulation would not mean that the device
has been ``cleared by FDA for home use'' within the context of 42 CFR
493.15, a regulatory provision related to the implementation of the
CLIA provisions found at 42 U.S.C. 263a.
    Package insert would mean all informational materials directed to
the user of the device, and which are provided in a device package or
which contemporaneously accompany the device when it is delivered to
the user, including by electronic means. Although the term is used in
section 510(j)(1)(b)(ii) of the FD&C Act (see the discussion of section
510(j) in section I. Background) and in various medical device
regulations, this term is not defined in the FD&C Act or by any medical
device regulation. A package insert is one type of device labeling. Our
definition of ``package insert'' in this proposed rule would also apply
only to proposed subpart F.
2. Conforming Proposed Amendment of Sec.  807.26(e)
    We would amend the first sentence of Sec.  807.26(e) to strike the
word ``only.'' This change is necessary to avoid conflict between the
proposed regulatory amendments pertaining to the submission of labels
and package inserts of home-use devices under new subpart F of this
proposed rule and Sec.  807.26(e), which states that owners or
operators shall be prepared to submit such information ``only upon
specific request'' (emphasis added). The submission of labeling for
home-use devices that new subpart F of this proposed rule would require
would not be responding to a targeted ``specific request'' for
information under existing Sec.  807.26(e). The proposed requirements
to submit such information under new subpart F would conflict with
Sec.  807.26(e), as currently worded, but would not conflict with
proposed Sec.  807.26(e), as amended. FDA does not intend this change
to result in a greater number of requests for information under Sec.
807.26(e), and we do not intend to request the resubmission of
information under Sec.  807.26(e) that has already been submitted for
home-use devices under new subpart F. Related Sec.  807.26(f)
prohibiting the submission of information requested under Sec.
807.26(e) from ``using the FDA electronic device registration and
listing system'' likewise would not apply to the information that would
be submitted under proposed new subpart F if finalized, which provides
instead for such information to be submitted ``in a format specified by
FDA that we can process, review, and archive'' (proposed Sec.
807.205).
3. Proposed Requirement To Submit the Label and Package Insert for
Certain Home-Use Devices
    We are proposing a new subpart to part 807, ``Subpart F--Submission
of Labeling When Listing Certain Home-Use Devices.'' For establishments
listing home-use devices subject to this proposed rule, proposed Sec.
807.205 would require that the device label and package insert be
submitted to FDA whenever any provision within part 807 requires
submission of listing information regarding the device.
    Proposed Sec.  807.220 would make clear that the voluntary
submission of the label and package insert of a home-use device that is
not required under this proposed rule would be permitted. Proposed
Sec.  807.220(a) would make clear that for such devices, including a
home-use device regulated by CBER, the owner or operator subject to
part 807 could voluntarily submit the device label and package insert,
which FDA could then make available to the public.
    Proposed Sec.  807.220(c) would make clear that the label and
package insert for a discontinued home-use device could be submitted,
which FDA could then make available to the public. This provision would
provide a way for an establishment to make information about a
discontinued home-use device available to the public, potentially
reducing the burden of responding to requests for information about a
discontinued device.
    Proposed Sec.  807.300 would explain when an updated device label
and package insert must be submitted.
    Proposed Sec.  807.300(a) would reduce the burdens of the proposed
rule, if finalized, following the initial submission of listing
information to FDA by making it clear that resubmission of the label
and package insert of a home-use device each year during the annual
listing process, and in other circumstances when updated listing
information must be submitted, would not be required unless changes
have been made. Instead, if no change has been made to the most-
recently submitted label and package insert, FDA would only require a
statement to that effect. We expect this statement will be as simple as
clicking a check-box within one of the processes FDA expects to
provide.
    Proposed Sec.  807.300(b) would make clear that updated labeling
information for a home-use device that is not required under this
proposed rule, such as a CBER-regulated home-use device, could
voluntarily be submitted at any time. We expect the majority of
labelers will see advantages to keeping this information up-to-date, as
a way of better serving current and potential users of their devices.
    We would make a conforming amendment to Sec.  807.40 to apply the
requirements of proposed subpart F to listings by foreign
establishments. This would ensure that both domestic and foreign
establishments will be subject to the same requirements regarding the
submission of labels and package inserts for home-use devices.

E. Effective Date

    FDA is proposing that this rule would go into effect 90 days after
publication of a final rule, if that results in an effective date prior
to October 1 of the year of publication; otherwise, the rule would go
into effect on January 1 of the year following publication of a final
rule. This ensures adequate notice and avoids any possibility that a
final rule might go into effect part way through an ongoing
registration and listing cycle (October 1 through December 31 each
year).
    The proposed rule would implement provisions of the FD&C Act to
require the submission of class II and class III home-use device labels
and package inserts with device listing information submitted to FDA on
or after the effective date of the rule. The rule would not be
retroactive, and there would be no obligation to submit the label or
package insert of a discontinued home-use device that was listed at any
time prior to the effective date of a final rule; but if that device is
listed during a subsequent registration and listing cycle (a cycle that
begins after the effective date of a final rule), all listing
requirements would have to be met, including submission of the label
and package insert.

IV. Legal Authority

    Section 510(j) of the FD&C Act requires all persons who register
with the Secretary to file a list of all devices that are being
manufactured, prepared, propagated, compounded, or processed by them
for commercial distribution. The listing of all devices is required to
be accompanied by a copy of the label, package insert, and a
representative sampling of the labeling for such devices. (See section
510(j)(1)(B)(ii).) Accordingly, FDA is issuing the provisions of this
proposed rule that would implement the listing requirement for the
submission of labels and package inserts for home-use medical devices
regulated by CDRH under section 510(j) and section 701(a), which
provides FDA the authority to issue regulations for the efficient
enforcement of the FD&C Act.
    The provisions of the proposed rule that would require the
electronic submission of labeling are issued under the authority of
sections 510(p) and 701(a) of the FD&C Act. Section 510(p) requires
that registrations and listings under section 510 be submitted to the
Secretary by electronic means unless the Secretary grants a request for
waiver because the use of electronic means is not reasonable for the
person requesting such waiver.
    The failure to include a device in a list required by section
510(j) causes the device to be misbranded under section 502(o) of the
FD&C Act. The failure to provide any information required by section
510(j) is a prohibited act under section 301(p) of the FD&C Act.

V. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 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). We
have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the proposed rule. We believe that this
proposed rule is not a significant regulatory action as defined by
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because annualized costs to small entities are estimated to
be less than 0.4 percent of firm revenue, we propose to 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 proposing ``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 $146 million, using the most current (2015) 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

    This rule proposes to implement provisions of the FD&C Act by
requiring firms to electronically submit to FDA the device labels and
package inserts, hereafter in this section of the document referred to
as ``labeling,'' of certain home-use medical devices. In particular,
all devices regulated by CDRH as class II and class III devices and
labeled for use in any environment outside a professional health care
facility would be covered by this rule. FDA intends to make the
labeling of these devices available to the public in a searchable FDA-
managed or partner Internet Web site, hereafter referred to in this
section of the document as ``labeling database.'' Firms would be
required to submit the device labeling to FDA, initially in PDF format
but later in SPL format. Firms would incur three types of costs as a
result of this rule: Costs to read and understand the rule, costs to
reformat labeling according to the rule, and costs to train personnel
to comply with the rule. FDA would incur costs to establish and
maintain the public online labeling database. The public would benefit
from access to information and instructions on the proper use of
medical devices in home settings.
    The costs and benefits of the proposed rule are summarized in the
table 1, entitled ``Economic Data: Costs and Benefits Statement.'' This
table shows the estimated average annualized costs and other quantified
but not monetized effects of this rule using both 7 and 3 percent
annual discount rates over a 10-year evaluation period. We estimate
that the present value of costs over 10 years would range from $48.5 to
$51.7 million at a 7 percent discount rate and from $52.5 to $56.5
million at a 3 percent discount rate. Annualizing these costs over 10
years yields estimated costs ranging from $6.5 to $6.9 million at a 7
percent discount rate and $6.0 to $6.4 million with a discount rate of
3 percent.
    As table 1 shows, the primary benefit stems from a reduced
incidence of adverse events due to the increased availability of
medical device labeling. We use, as a proxy for those most likely to
benefit from this proposed rule, individuals who receive instruction
from home health providers on the proper and safe use of their home-use
devices. We estimate that the present value number of home-use device
training events over 10 years is 66.9 million using a 7 percent
discount rate or 80.1 million using a 3 percent discount rate.
Annualized over 10 years, we estimate the annual number of home-use
device training events is 8.9 million with a 7 percent discount rate
and 9.1 million with a 3 percent discount rate. Under the proposed
rule, we estimate that for each home-use device training event, the
rule would cost between $0.73 and $0.77 using a 7 percent discount
rate; with a 3 percent discount rate, the cost per event would range
from $0.66 to $0.71.

                                                  Table 1--Economic Data: Costs and Benefits Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                                ---------------------------------------------
            Category              Primary estimate    Low  estimate      High  estimate       Year       Discount                            Notes
                                                                                dollars      rate (%)    Period  covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Monetized $millions/  .................  .................  .................  ...........            7
 year.                                                                                3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Quantified..........  8.9 million home-  .................  .................  ...........            7  10 years.........  Reduced incidence
                                  use device                                                                                of adverse
                                  training events.                                                                                events due to
                                                                                availability of
                                                                                labeling.
                                 9.1 million home-  .................  .................  ...........            3  10 years.........
                                  use device
                                  training events.
Qualitative
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Monetized $millions/  $6.6 million.....  $6.5 million.....  $6.9 million.....         2011            7  10 years.........  Includes industry
 year.                           $6.1 million.....  $6.0 million.....  $6.4 million.....         2011            3  10 years.........   costs to read
                                                                                and understand
                                                                                the rule,
                                                                                reformat
                                                                                labeling, and
                                                                                train personnel
                                                                                as well as FDA
                                                                                costs to
                                                                                establish and
                                                                                maintain the
                                                                                labeling
                                                                                database.
Annualized Quantified..........  .................  .................  .................  ...........            7
                                 .................  .................  .................  ...........            3  .................  .................
Qualitative
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Transfers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal Annualized Monetized     .................  .................  .................  ...........            7  .................  None.
 $millions/year.                                                                                3
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To........................  From:
                                 To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized       .................  .................  .................  ...........            7  .................  .................
 $millions/year.                                                                                3
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To........................  From:
                                 To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects.
--------------------------------------------------------------------------------------------------------------------------------------------------------
State, Local, or Tribal Government.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small Business.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual cost per affected small entity is estimated to be less than 0.4 percent of revenues.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Wages: No estimated effect.
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Growth: No estimated effect.
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Summary of Regulatory Flexibility Analysis

    To determine the impact of the proposed rule on small entities, we
compare the estimated cost of the rule to the average revenues of the
small entities. Assuming that each small firm is composed of a single
establishment, the annualized cost to small entities of the proposed
rule is not expected to exceed 0.22 percent of firm revenue. The
largest impact would be felt by firms with fewer than 100 employees. If
instead we assume that each small firm is composed of three
establishments, the annualized cost to small entities of the proposed
rule is not expected to exceed 0.38 percent of firm revenue. Given that
we estimate the cost of the proposed rule to be a very small percentage
of firm revenue, the Agency proposes to certify that this proposed rule
will not have a significant economic impact on a substantial number of
small entities.
    The full analysis of economic impacts is available in the docket
for this proposed rule (Ref. 12) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.

VI. Information Collection Requirements

    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 (44 U.S.C. 3501-3520). A
description of these provisions is given in the Description section of
this document with an estimate of the annual reporting burden. 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.
    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.
Medical Devices: Submission of Certain Home-Use Device Labels and
Package Inserts to FDA
    Description: This proposed rule implements statutory directives of
section 510(j) of the FD&C Act regarding information required to list a
medical device, and amendments enacted in 2002 and 2007 with respect to
section 510(p) of the FD&C Act that require all registration and
listing information to be submitted ``by electronic means'' (except
where FDA grants a waiver from the use of electronic means). The
collection requirements associated with this regulation will help
ensure that patients, caregivers, and health care professionals have
free, timely, and unimpeded access to a trusted source of comprehensive
information essential to the safe and effective use of class II and
class III home-use devices, even if such devices become separated from
their original labeling. We believe that the public will benefit from
the improved availability of information, accompanying search tools,
and links to other FDA information. Ultimately, it is FDA's hope that
access to this information will contribute to improved medical outcomes
and a reduction in adverse events.
    Specifically, if a home-use device is subject to the proposed rule
its label and any package insert would be required to be submitted
whenever that device is listed with FDA. Device listing information
must be submitted electronically to FDA once each year, during the
period from October 1 through December 31. Once a device's labeling has
been submitted to FDA, the establishment may thereafter either submit
revised labeling with each annual listing of the device to which it
pertains, or may certify that no change has been made to the previously
submitted labeling. The certification option would simplify the process
by not requiring the submission of materials that would duplicate
materials previously submitted to FDA. The proposed rule would make
clear that the voluntary submission of the label and package insert of
a home-use device would be permitted in some circumstances. When
finalized, the information collection requirements outlined in this
section will amend the current OMB PRA approval for the current
Registration and Listing Information collection approved under OMB
control number 0910-0625.
    Description of Respondents: The likely respondents for this
collection of information are domestic device establishments who plan
to sell, or who are continuing to sell, their products within the
United States.
    FDA estimates the burden, on average, of this collection of
information as follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
Section 510(p)/information collection activity     Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial Electronic Labeling Submission........           2,280          5.4114          12,338  0.25 (15 minutes).......................         3,084.5
Ongoing Annual Certification of Labeling                 2,280          1.0825           2,468  0.25 (15 minutes).......................             617
 Submission.
Ongoing Annual Electronic Labeling............           2,280               6          13,680  0.25 (15 minutes).......................           3,420
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................         7,121.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 ``Medical Devices: Submission of Home-Use
Device Labels and Package Inserts to FDA''.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), the Agency has submitted the information collection
provisions of this proposed rule to OMB for review. These requirements
will not be effective until FDA obtains OMB approval. FDA will publish
a notice concerning OMB approval of these requirements in the Federal
Register.

VII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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.

VIII. Proposed Effective Date

    FDA proposes that this rule will go into effect 90 days after
publication of a final rule, if that results in an effective date prior
to October 1 of the year of publication; otherwise, FDA proposes this
rule will go into effect on January 1 of the year following publication
of a final rule.

IX. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule, if finalized, does not contain policies that would
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 proposed 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.

X. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. ``Medical Device Home Use Initiative,'' FDA, April 2010,
available at http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM209056.pdf.
2. ``Guidance on Medical Device Patient Labeling; Final Guidance for
Industry and FDA Reviewers,'' FDA, April 2001, available at http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070782.htm.
3. ``Medical Instrumentation--Accessibility and Usability
Considerations,'' Jack M. Winters and Molly Follette Story, eds.,
CRC Press, 2007.
4. ``Basic Statistics About Home Care,'' The National Association
for Home Care and Hospice 2010, available at http://www.nahc.org/assets/1/7/10hc_stats.pdf.
5. ``CDRH Preliminary Internal Evaluations--Volume II: Task Force on
the Utilization of Science in Regulatory Decision Making,'' August
2010, p. 10, available at http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm220783.pdf.
6. ``CDRH Preliminary Internal Evaluations--Volume I: 510(k) Working
Group Preliminary Report and Recommendations,'' FDA, August 2010,
pp. 85-86, available at http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm220784.pdf.
7. ``510(k) and Science Report Recommendations: Summary and Overview
of Comments and Next Steps,'' FDA, January 2011, available at http://www.fda.gov/downloads/aboutfda/centersoffices/cdrh/cdrhreports/ucm239449.pdf.
8. Transcript of April 7, 2011, public meeting, ``Medical Device Use
in the Home Environment Workshop: Implications for the Safe and
Effective Use of Medical Device Technology Migrating into the Home''
(May 24, 2011), available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm215636.htm.
9. ``Medical Device Labeling for Health Care Practitioners: Focus
Group Study,'' RTI International, May 2011, OMB control number 0910-
0497, available at http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM335197.pdf.
10. ``Device Labeling Study: Practitioner Perspectives on Utility,
Format, and Content of an Abbreviated Version of Labeling: Report
Summary,'' RTI International, March 2013, OMB control number 0910-
0715, available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/ucm386369.htm.
11. ``Public Workshop--Medical Device Patient Labeling, September
29-30, 2015'' available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm455361.htm.
12. ``Preliminary Regulatory Impact Analysis, Initial Regulatory
Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for
Electronic Submission of Labeling for Certain Home-Use Medical
Devices,'' available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses//default.htm.

List of Subjects

21 CFR Part 807

    Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.

    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 part 807 be amended as follows:

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

0
1. The authority citation for part 807 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.

Sec.  807.26   [Amended]

0
2. Amend Sec.  807.26(e) introductory text by removing the word
``only''.

Sec.  807.40   [Amended]

0
3. Amend Sec.  807.40(a) by removing the words ``subpart B'' and adding
in their place ``subparts B and F''.
0
4. Add subpart F, consisting of Sec. Sec.  807.200 through 807.300, to
read as follows:
Subpart F--Submission of Labeling When Listing Certain Home-Use Devices
Sec.
807.200 Home-use device definitions.
807.205 Submission of labeling required for listing certain home-use
devices.
807.220 Voluntary submission of labeling for a home-use device.
807.300 When updated labeling for a home-use device must be
submitted to FDA.

Subpart F--Submission of Labeling When Listing Certain Home-Use
Devices

Sec.  807.200  Home-use device definitions.

    The definitions of this section apply only to this subpart and not
for other purpose, including the categorization of in vitro diagnostic
products under 42 CFR 493.15:
    Home-use device means a medical device that is labeled for use in
any environment outside a professional health care facility.
    Package insert means all informational materials directed to the
user of the device, and which are provided in a device package or which
contemporaneously accompany the device when it is delivered to the
user, including by electronic means.

Sec.  807.205  Submission of labeling required for listing certain
home-use devices.

    Whenever this part requires the owner or operator of an
establishment to submit listing information, and the listing concerns a
home-use device regulated by the Center for Devices and Radiological
Health as a class II or class III medical device, the owner or operator
must submit the label and package insert of that home-use device by
electronic means in a format specified by FDA that we can process,
review, and archive. If a waiver from filing registration and listing
information electronically has been obtained under Sec.  807.21(b), the
label and package insert shall be submitted in the same manner as other
registration and listing information, as directed by Sec.  807.34.

Sec.  807.220  Voluntary submission of labeling for a home-use device.

    (a) If listing a home-use device that is not regulated by the
Center for Devices and Radiological Health as a class II or class III
medical device, the owner or operator may submit the label and package
insert for the device.
    (b) If a listing of a home-use device represents more than one
product catalog or model number, the owner or operator may submit the
label and package insert for each catalog or model number.
    (c) An owner or operator may submit the label and package insert
for a home-use device that is not currently listed if that device was
previously listed pursuant to this part but has been discontinued.

Sec.  807.300  When updated labeling for a home-use device must be
submitted to FDA.

    (a) Whenever this part requires updated listing information to be
submitted, and the updated listing concerns a home-use device regulated
by the Center for Devices and Radiological Health as a class II or
class III medical device, the owner or operator shall determine whether
any change has been made to the labeling most-recently submitted to FDA
for the device. If any change has been made to the most recently
submitted labeling, the owner or operator shall submit the current
labeling. If no change has been made to the most recently submitted
labeling, the owner or operator shall provide a statement to that
effect.
    (b) The owner or operator may voluntarily submit updated labeling
for a listed device at any time prior to the time this part requires
such labeling to be submitted.

    Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25026 Filed 10-14-16; 8:45 am]
 BILLING CODE 4164-01-P