[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44935-44936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18923]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0453]


Draft Guidance for Industry and Food and Drug Administration 
Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) 
for a Change to an Existing Device; 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availability of the draft guidance entitled ``510(k) Device 
Modifications: Deciding When To Submit a 510(k) for a Change to an 
Existing Device.'' The recommendations in this guidance document are 
intended to describe when a new 510(k) should be submitted for a change 
or modification to a legally marketed device. This draft guidance is 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 25, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``510(k) Device Modifications: Deciding When 
To Submit a 510(k) for a Change to an Existing Device'' to the Division 
of Small Manufacturers, International, and Consumer Assistance, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Michael J. Ryan, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-
796-6283.

SUPPLEMENTARY INFORMATION:

I. Background

    Since the amendment of the Federal Food, Drug, and Cosmetic Act by 
the Medical Device Amendments of 1976, FDA has attempted to define with 
greater clarity when a modification to an existing medical device would 
trigger the requirement that a new premarket notification (510(k)) be 
submitted to the Agency and cleared prior to marketing. FDA regulations 
state in 21 CFR 807.81(a)(3) when a 510(k) must be submitted, but the 
language used in this regulation sometimes leads to varying 
interpretations of when a 510(k) is required for a device modification. 
In order to address this issue, FDA issued in 1997 the guidance 
document entitled ``Deciding When To Submit a 510(k) for a Change to an 
Existing 510(k)''; however, regulatory changes such as the 
implementation of the Quality System Regulation have occurred since 
that time, and medical device technology has evolved.

[[Page 44936]]

    In addition, in September 2009, FDA convened an internal 510(k) 
Working Group to conduct a comprehensive assessment of the 510(k) 
process. The 510(k) Working Group evaluated the 510(k) program with the 
goal of strengthening the program and improving the consistency in the 
Agency's decisionmaking process. In August 2010, the Center for Devices 
and Radiological Health (CDRH) published two documents in consideration 
of the comments made at the public meeting and the Agency's preliminary 
assessment of the program. These documents are titled ``CDRH 
Preliminary Internal Evaluations--Volume I: 510(k) Working Group 
Preliminary Report and Recommendations'' and ``CDRH Preliminary 
Internal Evaluations--Volume II: Task Force on the Utilization of 
Science in Regulatory Decision Making Preliminary Report and 
Recommendations'' (http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm). In January 2011, CDRH published the ``Plan 
of Action for Implementation of 510(k) and Science Recommendations'' 
(http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239450.pdf). One of the action items identified in the Plan of 
Action included publication of an update to the 1997 Device 
Modifications Guidance.
    The recommendations in this draft guidance document are consistent 
with longstanding FDA policy for when a modification to a device does 
and does not require the submission of a 510(k). The guidance has been 
updated, however, to address issues associated with software and other 
rapidly changing technologies, and to provide greater clarity about 
changes that do not trigger the need for a new premarket submission. 
This guidance uses examples of modifications to devices involving such 
technologies to illustrate changes that require a new 510(k), and 
changes that may simply be documented in accordance with a 
manufacturer's existing Quality System without prompting the need for a 
new 510(k) submission. FDA believes increased certainty about the 
regulatory consequences of device modifications is critical to 
facilitating advancements in device technology. FDA is specifically 
interested in seeking comments on the changes described, types of 
changes that are not covered by this document but should be, and 
illustrative examples of types of changes.

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 when a new 
510(k) should be submitted for a change or modification to a legally 
marketed device. 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 using 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. To receive 
the draft guidance entitled ``510(k) Device Modifications: Deciding 
When To Submit a 510(k) for a Change to an Existing Device,'' you may 
either send an e-mail request to dsmica@fda.hhs.gov to receive an 
electronic copy of the document or send a fax request to 301-847-8149 
to receive a hard copy. Please use the document number 1793 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 56.115 have been approved under 
OMB control number 0910-0130; the collections of information in 21 CFR 
part 801 have been approved under OMB control number 0910-0485; the 
collections of information in 21 CFR part 803 have been approved under 
OMB control number 0910-0437; the collections of information in 21 CFR 
part 807, subpart E 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; and the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

    Dated: July 21, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18923 Filed 7-26-11; 8:45 am]
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