[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Notices]
[Pages 14305-14306]
[FR Doc No: 2013-05015]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0147]

Draft Guidance for Industry and Food and Drug Administration
Staff; Types of Communication During the Review of Medical Device
Submissions; 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availability of the draft guidance entitled ``Types of Communication
During the Review of Medical Device Submissions.'' The purpose of this
guidance is to update the Agency's approach to Interactive Review to
reflect FDA's implementation of the Medical Device User Fee Act of 2007
(MDUFA II) Commitment Letters and of undertakings agreed in connection
with the Medical Device User Fee Amendments of 2012 (MDUFA III) and to
incorporate additional types of communication, all of which increase
the efficiency of the review process. This draft guidance is not final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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 3, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Types of Communication During the Review
of Medical Device Submissions'' 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 or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and

Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive
label to assist that office in processing your request, or fax your
request to<PHONE_NUMBER>. 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Samie Allen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1533, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
or Tami Belouin, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the letters dated September 27, 2007, from the Secretary of
Health and Human Services to the Chairman of the Committee on Health,
Education, Labor, and Pensions of the U.S. Senate and the Chairman of
the Committee on Energy and Commerce of the U.S. House of
Representatives setting out the goals of section 201(c) of MDUFA II,
Title II of the Food and Drug Administration Amendments of 2007 (FDAAA)
(21 U.S.C. 379i note), FDA committed to developing a guidance document
that describes an interactive review process between FDA and industry
for specific medical device premarket submissions. Further, during
discussions with representatives of the medical device industry in the
development of the Agency's recommendations for MDUFA III, Title II of
the Food and Drug Administration Safety and Innovation Act, Public Law
112-144 (July 9, 2012), 126 Stat. 1002 (21 U.S.C. 301 note), the Agency
proposed process improvements to provide further transparency into the
review process, including new communication commitments.
    This guidance describes four types of communication that occur
during the review of a medical device premarket submission. The four
types of communication are: Acceptance Review Communication,
Substantive Interaction, Interactive Review, and Missed MDUFA Decision
Communication.

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
communication during a medical device premarket submission review to
provide further transparency into, and to increase the efficiency of,
the review process. 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 either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. To receive ``Types
of Communication During the Review of Medical Device Submissions,'' you
may either send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document or send a fax request to<PHONE_NUMBER>
to receive a hard copy. Please use the document number 1804 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subpart B, have been approved under OMB
control number 0910-0231; and the collections of information in 21 CFR
part 601 have been approved under OMB control number 0910-0338.

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 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05015 Filed 3-4-13; 8:45 am]
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