[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Reporting Requirements; Draft Guidance for Industry and Food and Drug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availability of the draft guidance entitled ``Distinguishing Medical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This draft guidance intends to clarify for industry when a potential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 This draft
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 23, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Distinguishing Medical Device Recalls From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Submit electronic comments on the draft guidance to http://www.regulations.gov.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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