[Federal Register Volume 79, Number 199 (Wednesday, October 15, 2014)]
[Notices]
[Pages 61875-61876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0114]


Distinguishing Medical Device Recalls From Medical Device 
Enhancements; 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 a guidance entitled, ``Distinguishing Medical Device 
Recalls From Medical Device Enhancements.'' This guidance is intended 
to clarify when a potential change to a device is a medical device 
recall, distinguish those instances from product enhancements, and 
explain reporting requirements.

DATES: Submit either electronic or written comments on this guidance at 
any time.

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 single copies of the guidance document entitled, 
``Distinguishing Medical Device Recalls From Medical Device 
Enhancements'' 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. Send one self-addressed adhesive label to 
assist that office in processing your request.
    Submit electronic comments on the 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: Ronny Brown, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2654, Silver Spring, MD 20993-0002, 301-796-6163.

I. Background

    Defects or performance failures of marketed medical devices can 
pose serious risks to public health. The recall process serves both to 
correct the device defects and to notify users of potential risks and 
steps to minimize the impact of device failure or improper function. 
The recall process establishes a mechanism for firms that produce and 
market medical devices to take timely action to correct or remove 
violative devices.
    When a firm's recall process is operating effectively, the firm 
identifies a device defect or failure, determines that a recall is 
appropriate, and triggers the initiation of the recall process. 
However, firms may have trouble identifying whether a change to a 
device meets the definition of a recall, the appropriate scope of a 
recall, and when FDA should be notified of a recall. These issues can 
result in delays in notifying the public about unsafe medical devices.
    FDA also recognizes that continuous improvement activities, as part 
of an effective quality system, often have a favorable impact on 
medical device safety and are part of ongoing efforts to design and 
manufacture devices that meet the needs of the user and patient. When a 
new iteration of a device has improved design, for example, this does 
not necessarily mean that the prior version of the device should be 
recalled. Such changes may be appropriately characterized instead as 
product enhancements. In addition to determining whether a proposed 
change to a marketed device meets the definition of a device recall or 
a product enhancement, a firm must assess whether it is required to 
report the change to FDA.
    In the Federal Register of February 22, 2013 (78 FR 12329), FDA 
announced the availability of the draft guidance document. Interested 
persons were invited to comment by May 23, 2013. Multiple comments were 
received with recommendations pertaining to three main areas: (1) 
Clarification of definitions; (2) requests for more examples; and (3) 
clarification of reporting obligations pertaining to 21 CFR part 806. 
In response to these comments, FDA revised the guidance document to 
enhance clarity through the inclusion of multiple new examples. Some 
previously-included examples were deleted or reframed for improved 
clarity, and some content was removed since it did not enhance clarity 
and in some cases led to confusion. The guidance as revised provides 
more succinct information about the distinctions between medical device 
recalls and medical device enhancements and related reporting 
obligations. The guidance is organized in a question-and-answer format, 
providing responses to questions that FDA believes are helpful in 
properly identifying medical device recalls and applying reporting 
requirements.

II. Significance of Guidance

    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on the difference between a medical device 
recall and a

[[Page 61876]]

medical device enhancement. 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 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. Persons 
unable to download an electronic copy of ``Distinguishing Medical 
Device Recalls From Medical Device Enhancements,'' may send an email 
request to <a href="/cdn-cgi/l/email-protection#793a3d2b31543e0c101d18171a1c391f1d185711110a571e160f"><span class="__cf_email__" data-cfemail="c48780968ce983b1ada0a5aaa7a184a2a0a5eaacacb7eaa3abb2">[email protected]</span></a> to receive an electronic copy of 
the document. Please use the document number 1819 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    The 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 7, subpart C, have been 
approved under OMB control number 0910-0249; the collections of 
information in 21 CFR part 801 and 21 CFR 809.10 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; 
and the collections of information in 21 CFR part 810 have been 
approved under OMB control number 0910-0432.

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: October 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24446 Filed 10-14-14; 8:45 am]
BILLING CODE 4164-01-P


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