[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Notices]
[Pages 12329-12330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04060]


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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 Product Enhancements; 
Reporting Requirements; Draft Guidance for Industry and Food and Drug 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availability of the draft guidance entitled ``Distinguishing Medical 
Device Recalls From Product Enhancements; Reporting Requirements.'' 
This draft guidance intends to clarify for industry when a potential 
change to a device is a medical device recall, distinguish those 
instances from product enhancements, and identify the reporting 
requirements for both recalls and product enhancements. This draft 
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 23, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Distinguishing Medical Device Recalls From 
Product Enhancements; Reporting Requirements'' 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Ron 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. Recalls serve both to correct the 
defect in current and future devices and to notify users of potential 
risks and steps to minimize the impact of device failure or function. 
The recall process establishes a mechanism for firms that produce and 
market medical devices to take timely action to correct violative 
devices or remove them from the marketplace when correction or removal 
is necessary to protect the public health.
    When a firm's recall process is operating effectively, the firm 
identifies a device defect or failure, determines 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 
new iterations of a device involve improvements to device design, it 
does not necessarily mean that the existing device needs to 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

[[Page 12330]]

a product enhancement, a firm must make a separate assessment on 
whether it is required to report the change to FDA.
    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 the reporting 
requirements.

II. Significance of Guidance

    The 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 the 
difference between a recall and an enhancement to an existing premarket 
approval application (PMA) or 510(k). 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 
``Distinguishing Medical Device Recalls From Product Enhancements; 
Reporting Requirements,'' you may either send an email request to 
[email protected] 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 1819 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    The 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 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: February 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04060 Filed 2-21-13; 8:45 am]
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