[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]
BILLING CODE 4160-01-P