[Federal Register Volume 73, Number 1 (Wednesday, January 2, 2008)]
[Notices]
[Pages 194-196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-6268]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 [Docket No. 2007D-0492]


Guidance for Industry and Food and Drug Administration; 
Interactive Review for Medical Device Submissions: 510(k)s, Original 
PMAs, PMA Supplements, Original BLAs, and BLA Supplements; 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 ``Interactive Review for Medical 
Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original 
BLAs, and BLA Supplements.'' The purpose of this guidance document is 
to recommend an

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interactive premarket review process for these submissions that is 
designed to expedite FDA's review of device applications while 
continuing to assure device safety and effectiveness, in accordance 
with the goals of the Food and Drug Administration Amendments Act of 
2007 (FDAAA).

DATES:  Submit written or electronic comments on this guidance at any 
time. General comments on agency guidelines are welcome at any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
document entitled ``Interactive Review for Medical Device Submissions: 
510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA 
Supplements'' to the Division of Small Manufacturers, International, 
and Consumer Assistance (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 240-276-3151. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. 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 (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4013.

SUPPLEMENTARY INFORMATION:

I. Background

    In the letter from the Secretary of Health and Human Services to 
the Chairman of the Committee on Health, Education, Labor, and Pensions 
of the Senate setting out the goals of the Medical Device User Fee 
Amendments of 2007 (MDUFA) (see section 201(c) of FDAAA), dated 
September 27, 2007, FDA committed to developing a guidance document 
that describes an interactive review process between FDA and industry 
for specific medical device premarket submissions. While FDA committed 
to developing an interactive review process only for premarket 
notification submissions (510(k)s), premarket approval applications 
(PMAs), and PMA supplements, the agency believes that medical device 
Biologic License Applications (BLAs) could also benefit from such a 
process. Therefore, the guidance document also applies to medical 
device BLAs and BLA supplements.
    The goal of the interactive review process is to improve the 
timeliness of the review process for 510(k)s, PMAs, PMA supplements, 
BLAs and BLA supplements. FDA expects that the interactive review 
process will result in prompter approvals and clearances of medical 
devices and thereby improve the public health. FDA intends to reassess 
the interactive review process on a regular basis to determine whether 
it is meeting its intended objectives. When necessary, changes will be 
implemented to improve the efficiency of this process.
    FDA is making this guidance document immediately in effect because 
prior public participation was not feasible or appropriate. In the 
letter described in section 201(c) of FDAAA that sets out the goals of 
MDUFA, FDA committed to developing, within 3 months of the date of 
FDAAA's enactment, a guidance document that describes an interactive 
review process. The interactive review process supports a less 
burdensome approach to the premarket review process that is consistent 
with public health.

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 the interactive review process for 
premarket medical device submissions. 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. To receive ``Interactive Review for Medical Device 
Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, 
and BLA Supplements,'' you may either send an e-mail request to 
[email protected] to receive an electronic copy of the document or 
send a fax request to 240-276-3151 to receive a hard copy. Please use 
the document number 1655 to identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions [including 
lists of approved applications and manufacturers' addresses], small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

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. Sec. Sec.  3501-
3520) (the PRA). 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, subpart A, have been approved under OMB 
control number 0910-0338.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.
    Please note that in January 2008, the FDA website is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.


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    Dated: December 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-6268 Filed 12-27-07; 3:08 pm]
BILLING CODE 4160-01-S