FDA Draft Guidance; Providing Information about Pediatric Uses of Medical Devices
February 19, 2013
Dear Registered Establishment,
Today, the Food and Drug Administration (FDA) issued a proposed rule that requires manufactures to submit publicly available information on pediatric patients (21 years or younger) that suffer from the disease or condition that the devices submitted for FDA approval are intended to treat, diagnose, or cure. This information will help key stakeholders, device manufacturers, and the FDA track what devices are available to pediatric patients and identify unmet pediatric device needs. Once unmet needs are identified, device manufacturers and FDA staff can use this information to promote new device development and proper labeling of existing medical devices for pediatric use.
Under the proposed rule, any request for a humanitarian device exemption (HDE), premarket approval application (PMA), supplement to a PMA, or product development protocol (PDP) must include readily available pediatric use information.Providing the FDA with this information will not require additional clinical research or other costly efforts. It simply requires the applicant to briefly summarize readily available information that may have already been reviewed during the course of the development of the device and preparation of the medical device application submitted to the FDA.
The FDA also published a companion guidance to help manufactures understand and comply with the rule. The guidance document discusses the following topics:
- the types of medical device applications that must include the pediatric device use information;
- a description of the specific pediatric device use information required to comply with the law;
- what is meant by “readily available information”;
- where to include the pediatric device use information within an application;
- definitions of the pediatric patient population and of pediatric subpopulations;
- how to provide the pediatric device use information within the application;
- examples of acceptable sources that could address the pediatric use information requirement; and
- what FDA will do with the submitted pediatric device use information.
The public will have an opportunity to submit comments and suggestions regarding the proposed rule and the draft document within 60 days of publication in the Federal Register of the notice. 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.regulations.gov.
- Proposed Rule: Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure
- Draft Guidance: Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act
Thank you for your support of FDA and its mission.
Center for Devices and Radiological Health
Food and Drug Administration