[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Notices]
[Pages 14305-14306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05015]


-----------------------------------------------------------------------

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Draft Guidance for Industry and Food and Drug Administration 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.

-----------------------------------------------------------------------

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availability of the draft guidance entitled ``Types of Communication 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 This draft guidance is not final 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 3, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Types of Communication During the Review 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

[[Page 14306]]

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 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: 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 Tami Belouin, 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), 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 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: February 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05015 Filed 3-4-13; 8:45 am]
BILLING CODE 4160-01-P