[Federal Register: May 14, 2004 (Volume 69, Number 94)]
[Notices]               
[Page 26868-26869]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my04-56]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0319]

 
Guidance for Industry and Food and Drug Administration Staff; 
Premarket Assessment of Pediatric Medical Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Premarket Assessment of 
Pediatric Medical Devices.'' This 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.

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

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the 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 one 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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

[[Page 26869]]

Samuels-Reid, Center for Devices and Radiological Health (HFZ-480), 
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850, 301-594-1287.
    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.
    On February 4, 2003, FDA published a Federal Register document 
entitled, ``Medical Device User Fee and Modernization Act of 2003, 
Establishment of a Public Docket'' (68 FR 5643) (hereinafter referred 
to as the MDUFMA Docket). In this Federal Register document, the agency 
identified several statutory provisions for which FDA was particularly 
interested in receiving stakeholder input, and this pediatric provision 
was one of them. No comments were submitted to the MDUFMA Docket on 
this topic. In the Federal Register of July 24, 2003 (68 FR 43729), FDA 
announced the availability of a draft of this guidance document and 
invited interested persons to comment by October 22, 2003. Three 
comments were submitted in response to the draft guidance, and the 
agency considered the comments while finalizing the document.

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 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, call the Center for Devices and Radiological Health (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 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. The CDRH web 
site may be accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/.

cdrh/guidance.html. Guidance documents are also available on the 
Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 (44 U.S.C. 3501-3520) (the PRA). 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing premarket 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 
OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document 
at any time. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except individuals may submit one paper 
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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: May 5, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11028 Filed 5-13-04; 8:45 am]

BILLING CODE 4160-01-S