[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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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]]

    <bullet> 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 <a href="/cdn-cgi/l/email-protection#b4f7f0e6fc99f3c1ddd0d5dad7d1f4d2d0d59adcdcc79ad3dbc2"><span class="__cf_email__" data-cfemail="662522342e4b21130f020708050326000207480e0e1548010910">[email protected]</span></a> 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]]



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


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