[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Notices]
[Pages 18918-18919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07546]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0147]
Types of Communication During the Review of Medical Device
Submissions; 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 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 and
other additional types of communication, to reflect FDA's
implementation of the Medical Device User Fee Act of 2007 (MDUFA II)
Commitment Letters and of undertakings agreed to in connection with the
Medical Device User Fee Amendments of 2012 (MDUFA III). These new
Agency communication commitments are to increase the efficiency of the
review process.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome 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 ``Types of
Communication During the Review of Medical Device Submissions'' 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 or the Office of Communication, Outreach and Development (HFM-40),
Center for Biologics Evaluation and Research (CBER), Food and
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 301-847-8149. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
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: 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, 301-796-6055,
or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448, 301-827-6210.
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) (21 U.S.C. 301 note), the Agency proposed
process improvements to provide further transparency into the review
process, including new communication commitments.
In the Federal Register on March 5, 2013 (78 FR 14305), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by June 3, 2013. Four comments were
received and, in general, were supportive of the guidance. However, the
comments contained multiple recommendations pertaining to the content
of the guidance and the need for clarification, particularly for the
Interactive Review section. In response to these comments, FDA revised
the guidance document to restructure the Interactive Review section to
clarify how this process works and to include references to additional
submission types for which Interactive Review pertains. Although
several commenters expressed concern about FDA's intention to limit the
last round of Interactive Review to 7 days, we did not modify the
guidance because this approach is needed in order to appropriately
balance the intent of interactive review with FDA's commitment to meet
the performance goals agreed upon as part of MDUFA III. In response to
comments regarding our intention to limit the issuance of second
Additional Information (AI) letters for 510(k) submissions, the
guidance was modified slightly to clarify the circumstances in which a
second AI letter might be issued, but remains unchanged in explaining
that these circumstances will remain limited and at FDA's discretion.
FDA will continually assess any impacts that the limited use of a
second AI letter may have, and, if needed, may consider modifications
to this approach. In addition to modifications to the Interactive
Review section, we clarified other items throughout the guidance, and
included Pre-Submissions as a submission type subject to Acceptance
Communication. This document supersedes ``Interactive Review for
Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements,
Original BLAs, and BLA Supplements'' dated February 28, 2008.
II. Significance of Guidance
This 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 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 guidance may do so by
using the Internet. A search capability for all Center for Devices and
Radiological Health guidance documents is available at http://
www.fda.gov/MedicalDevices/
[[Page 18919]]
DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or from CBER
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``Types
of Communication During the Review of Medical Device Submissions,'' 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 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: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07546 Filed 4-3-14; 8:45 am]
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