[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
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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 [email protected] 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]
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