[Federal Register: January 2, 2008 (Volume 73, Number 1)]
[Notices]
[Page 194-196]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ja08-61]
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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
[[Page 195]]
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
dsmica@fda.hhs.gov 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.
[[Page 196]]
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