[Federal Register Volume 69, Number 118 (Monday, June 21, 2004)]
[Pages 34374-34375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13872]



Food and Drug Administration

[Docket No. 2004N-0254]

Possible Barriers to the Availability of Medical Devices Intended 
to Treat or Diagnose Diseases and Conditions that Affect Children; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA), Center for Devices and 
Radiological Health (CDRH), is requesting comments concerning the 
possible barriers to the availability of medical devices intended to 
treat or diagnose diseases and conditions that affect children. This 
action is being taken to assist the agency in preparing a report to 
Congress required by the Medical Devices Technical Corrections Act of 
2004 (MDTCA).

DATES: Submit written or electronic comments by August 20, 2004.

ADDRESSES: Submit written comments 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.

FOR FURTHER INFORMATION CONTACT: Joanne Less, Center for Devices and 
Radiological Health, Food and Drug Administration, 9200 Corporate 
Blvd., Rockville, MD 20850, 301-594-1190.

SUPPLEMENTARY INFORMATION: The President signed MDTCA (Public Law 108-
214) into law on April 1, 2004. Section 3 of the MDTCA was added to 
address potential difficulties in bringing pediatric devices to market. 
Over the last few months, several professional organizations 
representing pediatric interests expressed concern about the 
availability of safe and effective devices intended for this 
population. Representatives from CDRH and the Office of Pediatric 
Therapeutics met with these organizations to explore the issue. The 
agency has also received anecdotal reports suggesting there is an unmet 
need in the pediatric population, but additional information is needed 
to assess the accuracy of these reports.
    By October 1, 2004, the new law requires FDA to submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives a 
report addressing the ``barriers to the availability of devices 
intended for treatment or diagnosis of diseases and conditions that 
affect children.'' The law also states that the report must include 
``any recommendations of the Secretary of Health and Human Services for 
changes to existing statutory authority, regulations, or agency policy 
or practice to encourage the invention and development of such 
    Through this notice, FDA is soliciting comments that will help the 
agency draft its report to Congress under section 3 of MDTCA. In 
particular, FDA seeks input in response to the following questions:
    1. What are the unmet medical device needs in the pediatric 
population (neonates, infants, children, and adolescents)? Are they 
focused in certain medical specialties and/or pediatric subpopulations?
    2. What are the possible barriers to the development of new 
pediatric devices? Are there regulatory hurdles? Clinical hindrances? 
Economic issues? Legal issues?
    3. What could FDA do to facilitate the development of devices 
intended for the pediatric population? Are there changes to the law, 
regulation, or premarket process that would encourage clinical 
investigators, sponsors, and manufacturers to pursue clinical trials 
and/or marketing of pediatric devices?
    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

[[Page 34375]]

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.

    Dated: June 7, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-13872 Filed 6-18-04; 8:45 am]