[Federal Register: July 24, 2003 (Volume 68, Number 142)]
[Notices]
[Page 43729-43730]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jy03-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0319]
Draft Guidance for Industry and FDA Staff; Premarket Assessment
of Pediatric Medical Devices; 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availability of the draft guidance entitled ``Premarket Assessment of
Pediatric Medical Devices.'' This draft guidance presents FDA's current
thinking on the type of safety and effectiveness information needed to
support marketing of pediatric devices and on measures to be used to
help protect this vulnerable patient population during the course of
clinical trials involving such products. This draft guidance is neither
final nor is it in effect at this time.
DATES: Submit written or electronic comments on this guidance by
October 22, 2003.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``Premarket Assessment
of Pediatric Medical Devices'' 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 two self-addressed adhesive labels to
assist that office in processing your request, or fax your request to
301-443-8818. 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 http://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
For device issues contact: Joy Samuels-Reid, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1287 ext. 177.
For biologics issues contact: Edward Tabor, Center for Biologics
Evaluation and Research (HFM-300), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-3518.
SUPPLEMENTARY INFORMATION:
I. Background
On October 26, 2002, the Medical Device User Fee and Modernization
Act of 2002 (MDUFMA), Public Law 107-250, was signed into law. Among
other things, MDUFMA amends the Federal, Food, Drug, and Cosmetic Act
(the act) by adding several new provisions concerning devices intended
for pediatric use. MDUFMA requires FDA, within 270 days of enactment,
to issue guidance on the safety and effectiveness information needed to
support marketing of pediatric devices and on measures to be used to
help protect this vulnerable patient population during the course of
clinical trials involving such products. This guidance, as well as a
collateral guidance on procedures for ensuring appropriate pediatric
expertise on FDA Advisory Panels, ``Pediatric Expertise for Advisory
Panels'' (http://www.fda.gov/cdrh/ode/guidance/1208.html), will help
the agency achieve the intent of the pediatric provisions of MDUFMA.
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
represents the agency's current thinking on ``Premarket Assessment of
Pediatric Medical Devices.'' 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
To receive ``Premarket Assessment of Pediatric Medical Devices'' by
fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or
301-827-0111 from a touch-tone telephone. Press 1 to enter the system.
At the second voice prompt, press 1 to order a document. Enter the
document number (1220) followed by the pound sign (). Follow
the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance may
also do so by using the Internet. 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 contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) .
The collections of information addressed in the guidance document have
been approved by OMB in accordance with the PRA under the regulations
governing premarket
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notification submissions (21 CFR part 807, subpart E, OMB control
number 0910-0120) and premarket approval applications (21 CFR part 814,
OMB control number 0910-0231). The labeling provisions addressed in the
guidance have been approved by OMB under the PRA under OMB No. 0910-
0485.
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 to http://www.fda.gov/dockets/ecomments.
Submit two paper copies of any mailed
comments, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments received may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 18, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-18909 Filed 7-21-03; 4:25 pm]
BILLING CODE 4160-01-S