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 devices.”

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 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.