[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1747-1749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01022]


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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; 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 a final 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 (FD&C Act).

DATES: The announcement of the guidance is published in the Federal 
Register on February 5, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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

[[Page 1748]]

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; Guidance for Industry and Food and Drug Administration 
Staff.'' 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 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. 
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; or 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, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    The FD&C Act, as amended by the Food and Drug Administration 
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 FDA 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 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 
relevant regulatory question or issue through the most efficient manner 
at the right time. This 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.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of December 15, 2017 (82 FR 59623). 
FDA revised the guidance as appropriate in response to the comments. 
Among the comments that FDA received were those regarding metrics 
assessing the application of least burdensome principles and internal 
training on least burdensome principles. FDA issued a Report to 
Congress entitled ``Least Burdensome Training Audit'' pursuant to 
section 513(j) of the FD&C Act (21 U.S.C. 360c(j)), as added by the 
Cures Act.\1\ This report summarizes the mandatory training on least 
burdensome requirements for device review staff and supervisors and 
outcome of an audit of such training.
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    \1\ FDA Report to Congress, ``Least Burdensome Training Audit,'' 
June 8, 2018, available at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM610577.pdf.
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    This guidance document replaces the 2002 Least Burdensome Guidance

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entitled ``The Least Burdensome Provisions of the FDA Modernization Act 
of 1997: Concept and Principles'' (October 4, 2002).

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 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.regulations.gov or 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``The Least Burdensome Provisions: 
Concept and Principles; 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 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, form, and statutory provision 
have been approved by OMB as listed in the following table:

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    21 CFR part or section;                                 OMB control
 guidance; FDA form; or statute           Topic                 No.
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820............................  Quality System                0910-0073
                                  Regulation.
812............................  Investigational Device        0910-0078
                                  Exemption.
807, subpart E.................  Premarket Notification.       0910-0120
860.123........................  Reclassification              0910-0138
                                  Petition.
814, subparts A through E......  Premarket Approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
806............................  Medical Devices;              0910-0359
                                  Reports of Corrections
                                  and Removals.
803............................  Medical Device                0910-0437
                                  Reporting.
822............................  Postmarket Surveillance       0910-0449
Form FDA 3670..................  Adverse Event Reports/        0910-0471
                                  MedSun Program.
801 and 809....................  Labeling...............       0910-0485
``Recommendations for 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.
807, 812, and 814..............  Human Subject                 0910-0741
                                  Protection; Acceptance
                                  of Data from Clinical
                                  Studies for Medical
                                  Devices.
``Requests for Feedback on       Q-Submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
42 U.S.C. 241..................  Electronic Submission         0910-0769
                                  of Allegations of
                                  Regulatory Misconduct
                                  Associated with
                                  Medical Devices.
830............................  Unique Device                 0910-0720
                                  Identification System.
``De Novo Classification         De Novo Classification        0910-0844
 Process (Evaluation of           Process.
 Automatic Class III
 Designation)''.
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    Dated: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01022 Filed 2-4-19; 8:45 am]
 BILLING CODE 4164-01-P