[Federal Register Volume 84, Number 178 (Friday, September 13, 2019)]
[Notices]
[Pages 48358-48359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3304]


The Special 510(k) Program; 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 ``The Special 510(k) 
Program.'' FDA established the Special 510(k) Program to facilitate the 
submission, review, and clearance of changes to a manufacturer's own 
legally marketed predicate device. This guidance provides the framework 
that FDA uses when considering whether a premarket notification 
(510(k)) is appropriate for review as a Special 510(k).

DATES: The announcement of the guidance is published in the Federal 
Register on September 13, 2019.

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-2018-D-3304 for ``The Special 510(k) Program.'' 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 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 ``The 
Special 510(k) Program'' to the Office of Policy, 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: 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; Angela DeMarco, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
1611, Silver Spring, MD 20993-0002, 301-796-4471; or Stephen Ripley, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,

[[Page 48359]]

Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    On March 20, 1998, FDA issued the guidance document, ``The New 
510(k) Paradigm: Alternate Approaches to Demonstrating Substantial 
Equivalence in Premarket Notifications,'' which established the Special 
510(k) Program. By establishing the Special 510(k) Program, FDA sought 
to create an efficient review process for certain changes subject to 
510(k) submission requirements by leveraging design control 
requirements. The Special 510(k) Program allows manufacturers that are 
intending to change their own legally marketed device to utilize risk 
analysis and verification and validation activities to facilitate 
submission, review, and clearance of the change. While FDA intends to 
review Special 510(k)s within 30 days, the Special 510(k) Program does 
not alter any statutory or regulatory requirements related to the 
510(k) process under sections 510 and 513 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360 and 360c) and 21 CFR part 807, subpart 
E.
    To improve the efficiency of 510(k) review, FDA has updated the 
Special 510(k) Program to both clarify existing policy and the types of 
changes appropriate for the program. This guidance explains the factors 
FDA uses when considering whether a 510(k) is appropriate for review as 
a Special 510(k). In general, a change to an existing device may be 
appropriate for a Special 510(k) when: (1) The proposed change is 
submitted by the manufacturer legally authorized to market the existing 
device; (2) performance data are unnecessary, or if performance data 
are necessary, well-established methods are available to evaluate the 
change; and (3) all performance data necessary to support substantial 
equivalence can be reviewed in a summary or risk analysis format.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of September 28, 2018 (83 FR 49097). 
FDA revised the guidance as appropriate in response to the comments. 
This document supersedes the Special 510(k) content in ``The New 510(k) 
Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence 
in Premarket Notifications,'' issued on March 20, 1998.

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 ``The Special 510(k) Program.'' 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. This 
guidance document is also available at https://www.regulations.gov or 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to 
download an electronic copy of ``The Special 510(k) Program'' may send 
an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 18008 and complete 
title of the guidance in the request 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 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 and guidance have been approved by OMB as 
listed in the following table:

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  21 CFR part; guidance; or FDA
               form                       Topic          OMB control No.
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807, subpart E...................  Premarket                   0910-0120
                                    Notification.
801..............................  Medical Device              0910-0485
                                    Labeling
                                    Regulations.
820..............................  Current Good                0910-0073
                                    Manufacturing
                                    Practice (CGMP);
                                    Quality System
                                    (QS) Regulation.
``Requests for Feedback and        Q-submissions......         0910-0756
 Meetings for Medical Device
 Submissions: The Q Submission
 Program and Meetings with Food
 and Drug Administration Staff''.
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    Dated: September 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19881 Filed 9-12-19; 8:45 am]
 BILLING CODE 4164-01-P


