[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46738-46740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19989]
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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; 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 ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical
Devices.'' Voluntary consensus standards can be a valuable resource for
industry and FDA staff because such standards can increase
predictability, streamline premarket review, provide clearer regulatory
expectations, and facilitate market entry for safe and effective
medical products. FDA developed this document to provide guidance to
industry and FDA reviewers about the appropriate use of voluntary
consensus standards in the preparation and evaluation of premarket
submissions for medical devices. This guidance applies to all articles
that meet the definition of a ``device'' under the Federal Food, Drug,
and Cosmetic Act (FD&C Act).
DATES: The announcement of the guidance is published in the Federal
Register on September 14, 2018.
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 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-2014-D-0456 for ``Appropriate Use of Voluntary Consensus Standards
in Premarket Submissions for Medical Devices.'' 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.
[[Page 46739]]
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
``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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002 or 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: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002, 301-796-6287;
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, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
In 1996, Congress passed the National Technology Transfer and
Advancement Act (NTTAA) (Pub. L. 104-113). The NTTAA codified guidance
previously issued by the Office of Management and Budget (OMB), which
had established a policy to use voluntary consensus standards in lieu
of government-unique standards except where voluntary consensus
standards are inconsistent with law or otherwise impractical. Section
514(c) of the FD&C Act provides FDA the authority to recognize
voluntary consensus standards and accept declarations of conformity to
such standards (see 21 U.S.C. 360d(c)).
Voluntary consensus standards can be a valuable resource for
industry and FDA staff because such standards can increase
predictability, streamline premarket review, provide clearer regulatory
expectations, and facilitate market entry for safe and effective
medical products. The Agency developed this document to provide
guidance to industry and FDA staff about the appropriate use of
voluntary consensus standards in the preparation and evaluation of
premarket submissions for medical devices. This guidance applies to all
articles that meet the definition of a ``device'' under section 201(h)
of the FD&C Act (21 U.S.C. 321(h)).
FDA considered comments received on the draft guidance that
appeared in the Federal Register of May 13, 2014 (79 FR 27311). FDA
revised the guidance as appropriate in response to the comments. This
guidance supersedes: (1) ``Guidance for Industry and FDA Staff;
Recognition and Use of Consensus Standards,'' issued on September 17,
2007; (2) ``Frequently Asked Questions on Recognition of Consensus
Standards,'' issued on September 17, 2007; and (3) ``Guidance for
Industry and for FDA Staff: Use of Standards in Substantial Equivalence
Determinations,'' issued on March 12, 2000.
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 ``Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for Medical Devices.'' 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. Guidance
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. 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 guidance refers to previously approved collections of
information. These collections of information are subject to review by
the 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 form have been approved by OMB as listed in the following
table:
[[Page 46740]]
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OMB control
21 CFR part. guidance, or FDA form Topic No.
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807, subpart E and Form FDA 3654.. Premarket 0910-0120
Notification.
814, subparts A through E......... Premarket Approval.. 0910-0231
814, subpart H.................... Humanitarian Device 0910-0332
Exemption.
``Requests for Feedback on Medical Q-Submissions....... 0910-0756
Device Submissions: The Pre-
Submission Program and Meetings
with Food and Drug Administration
Staff``.
820............................... Current Good 0910-0073
Manufacturing
Practice; Quality
System Regulation.
312............................... Investigational New 0910-0014
Drug Regulation.
601............................... Biologics License 0910-0338
Application.
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Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19989 Filed 9-13-18; 8:45 am]
BILLING CODE 4164-01-P