[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Pages 27311-27312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10905]
[[Page 27311]]
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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Submissions for Medical Devices; Draft Guidance for Industry and Food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availability of the draft guidance entitled ``Appropriate Use of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 This draft guidance is not final nor is it in effect at this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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 11, 2014.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requests for a single hard copy of the draft guidance document entitled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 [email protected] 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]
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