
[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Pages 27311-27312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10905]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0456]


Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices; Draft Guidance for Industry and Food 
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices.'' FDA developed this draft document to provide guidance about 
the appropriate use of national and international voluntary consensus 
standards in the preparation and evaluation of premarket submissions 
for medical devices. This document also discusses procedures for the 
appropriate use of consensus standards, both recognized and non-
recognized, limitations on the use of consensus standards, and the 
content of a Declaration of Conformity to FDA-recognized consensus 
standards. This draft guidance is not final nor is it in effect at this 
time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 11, 2014.

ADDRESSES: 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requests for a single hard copy of the draft guidance document entitled 
``Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices'' to the Office of the Center Director, 
Guidance and Policy Development, Center for Devices and Radiological 
Health (CDRH), 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 (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: 
    For devices regulated by CDRH: Scott Colburn, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993-0002, 301-
796-6287.
    For devices regulated by CBER: Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.

I. Background

    This draft guidance provides information to industry and FDA 
reviewers about the appropriate use of national and international 
voluntary consensus standards in the preparation and evaluation of 
premarket submissions for medical devices. This document intends to 
clarify and explain the regulatory framework, policies, and practices 
underlying the appropriate utilization of voluntary consensus standards 
in the premarket review program. Additionally, the guidance provides 
information about the general use of voluntary consensus standards as 
well as the appropriate use of the declaration of conformity to 
consensus standards that have been recognized by FDA under section 
514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c). 
The draft guidance also proposes two changes in policy. The first 
proposal is for declarations of conformity to no longer be used when 
the submitter deviates from an FDA-recognized standard. The second 
proposal is for promissory statements indicating future conformance 
with a consensus standard to no longer be used. FDA intends to update 
other related guidance documents accordingly once this guidance is 
finalized. This guidance is not intended to address the specific 
content needed to support the approval or clearance of any particular 
premarket submission.

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 Agency's current thinking on the 
appropriate use of voluntary consensus standards in premarket 
submissions for medical devices. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute and regulations.

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 CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Persons unable to download an electronic copy of 
``Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1770 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. 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 21 CFR part 807, subpart E, and FDA Form 
3654, have been approved under OMB control number 0910-0120; the 
collections of information in 21 CFR part 812 have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
part 814 have been approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 814, subpart H, have been 
approved under OMB control number 0910-0332; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; the collections of information in 21 CFR part 312 
have been approved under OMB control number 0910-0014; and the 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338.

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V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: May 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10905 Filed 5-12-14; 8:45 am]
BILLING CODE 4160-01-P


