[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]
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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.
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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