[Federal Register Volume 82, Number 240 (Friday, December 15, 2017)]
[Notices]
[Pages 59623-59625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26987]


-----------------------------------------------------------------------

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The Least Burdensome Provisions: Concept and Principles; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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

-----------------------------------------------------------------------

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the availability of the draft guidance entitled ``The Least Burdensome 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 This draft guidance is not final 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DATES: Submit either electronic or written comments on the draft 
guidance by February 13, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[Page 59624]]

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, 240-402-7911.

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:

------------------------------------------------------------------------
                                                            OMB control
21 CFR part; guidance; or FDA form          Topic               No.
------------------------------------------------------------------------
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.

[[Page 59625]]

 
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.
------------------------------------------------------------------------


    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