[Federal Register Volume 68, Number 142 (Thursday, July 24, 2003)]
[Notices]
[Pages 43729-43730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18909]


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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Draft Guidance for Industry and FDA Staff; Premarket Assessment 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availability of the draft guidance entitled ``Premarket Assessment of 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 This draft guidance presents FDA's current 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 This draft guidance is neither 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diskette of the draft guidance document entitled ``Premarket Assessment 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