[Federal Register Volume 82, Number 240 (Friday, December 15, 2017)]
[Notices]
[Pages 59623-59625]
[FR Doc No: 2017-26987]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6702]

The Least Burdensome Provisions: Concept and Principles; Draft
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``The Least Burdensome
Provisions: Concept and Principles'' FDA utilizes a least burdensome
approach to medical device regulation to eliminate unnecessary burdens
that may delay the marketing of beneficial new products, while
maintaining the statutory requirements for clearance and approval. This
document describes the guiding principles and recommended approach for
FDA staff and industry to facilitate consistent application of least
burdensome principles to the activities pertaining to products meeting
the statutory definition of a device regulated under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final
nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by February 13, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6702 for ``The Least Burdensome Provisions: Concept and
Principles; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For

more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``The Least Burdensome Provisions: Concept and Principles'' to the
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002; or to the Office of Communication, Outreach, and Development,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Joshua Silverstein, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-
796-5155; and Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The FD&C Act, as amended by the FDA Modernization Act of 1997, the
FDA Safety and Innovation Act (FDASIA), and the 21st Century Cures Act
(Cures Act), includes least burdensome provisions that direct the Food
and Drug Administration (FDA or Agency) to take a least burdensome
approach to medical device evaluation in a manner that eliminates
unnecessary burdens that may delay the marketing of beneficial new
products, while maintaining the statutory requirements for clearance
and approval. The updates to the least burdensome provisions in FDASIA
and the Cures Act clarified the original least burdensome provisions
and further recognized the role of postmarket activities as they relate
to premarket decisions. FDA believes, as a matter of policy, that least
burdensome principles should be consistently and widely applied to all
activities in the premarket and postmarket settings to remove or reduce
unnecessary burdens so that patients can have earlier and continued
access to high quality, safe, and effective devices. This draft
guidance, therefore, reflects FDA's belief that least burdensome
principles should be applied throughout the medical device total
product lifecycle.
    For the purposes of this guidance, FDA defines ``least burdensome''
as the minimum amount of information necessary to adequately address a
regulatory question or issue through the most efficient manner at the
right time. This draft guidance describes the least burdensome guiding
principles and recommended approach for FDA staff and industry to
ensure consistent application of least burdensome principles to the
activities pertaining to products meeting the statutory definition of a
device regulated under the FD&C Act. This guidance document, when
finalized, will replace the 2002 Least Burdensome Guidance entitled
``The Least Burdensome Provisions of the FDA Modernization Act of 1997:
Concept and Principles'' (October 4, 2002).

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``The Least
Burdensome Provisions: Concept and Principles.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download
an electronic copy of ``The Least Burdensome Provisions: Concept and
Principles; Draft Guidance for Industry and Food and Drug
Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 1332 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information. These collections of information 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). The collections of information in
the following FDA regulations, guidance, and forms have been approved
by OMB as listed in the following table:

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                                                            OMB control
21 CFR part; guidance; or FDA form          Topic               No.
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820...............................  Quality system             0910-0073
                                     regulation.
812...............................  Investigational            0910-0078
                                     device exemption.
807, subpart E....................  Premarket                  0910-0120
                                     notification.
860.123...........................  Reclassification           0910-0138
                                     petition.
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian device        0910-0332
                                     exemption.
803...............................  Medical device             0910-0437
                                     reporting.
822...............................  Postmarket                 0910-0449
                                     surveillance.
Form FDA 3670.....................  Adverse event              0910-0471
                                     reports/MedSun
                                     program.

801 and 809.......................  Labeling............       0910-0485
``Recommendations: Clinical         CLIA waiver.........       0910-0598
 Laboratory Improvement Amendments
 of 1988 (CLIA) Waiver
 Applications for Manufacturers of
 In Vitro Diagnostic Devices''.
807, subparts A through D.........  Registration and           0910-0625
                                     listing.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
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    Dated: December 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26987 Filed 12-14-17; 8:45 am]
BILLING CODE 4164-01-P