FDA Seeks to Implement Pediatric Data Requirement
To speed development of products to treat unmet medical needs in children, the U.S. Food and Drug Administration (FDA) has issued a supplemental proposed rule that would require manufacturers to submit information on pediatric patients who suffer from the disease or condition that the devices are intended to treat, diagnose, or cure. The agency identifies the pediatric population as patients 21 years of age or younger.
Under the proposed rule, published in the Feb. 19 Federal Register, any request for a humanitarian device exemption, premarket approval application (PMA), supplement to a PMA, or product development protocol must include what the FDA calls “readily available” pediatric use information.In draft companion guidance accompanying the rule, readily available information is defined as material offered in the public domain, including data in such scientific research resources as MEDLINE and PubMed or from online medical publishers Public Library of Science and the Cochrane Library.
The guidance also lists the following unacceptable sources of data:
- Internal marketing tracking
- Sales records
- Research and development reports
- Consultation with pediatric experts
- Unpublished presentations or abstracts from major professional meetings
For PMA supplements, applicants should state if there is no new pediatric data available and reference their most recent submission containing applicable device use information.
The FDA emphasizes that the new requirements shouldn’t impose too much of a burden on companies, as no additional clinical research is required.
If a manufacturer doesn’t include the required pediatric information with its application, but has met all other regulatory and statutory requirements, the FDA will inform the applicant that its device will be approved once the pediatric data is provided.
The move to include pediatric data in applications comes almost three years after the agency issued a direct final rule that contained similar requirements. It withdrew the rule, published in the April 1, 2010 Federal Register, after receiving “significant adverse comment.” The new proposed rule addresses some of the comments the FDA received, including one about the requirement that sponsors include information about potential pediatric uses.
Interested parties may submit comments on the proposed rule by April 22. To read the proposed rule, please go here. To see the draft guidance, please click here.
Posted: February 21, 2013