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FDA Guidance - Premarket Assessment of Pediatric Medical Devices (Draft)
Premarket Assessment of Pediatric Medical Devices
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
I. Background
FDA reviews pediatric devices through all of its premarket pathways, including premarket notification (510(k)), premarket approval (PMA), biological license application (BLA), and humanitarian device exemption (HDE). A manufacturer may show substantial equivalence to a predicate device, or may seek marketing approval by demonstrating with reasonable assurance that the device is safe and effective for its intended use. Clinical evaluation may be needed to support marketing of a device indicated for pediatric use. If such studies are needed, they should be conducted in accordance with the investigational device exemptions (IDE) regulation (21 CFR 812). FDA has jurisdiction over significant risk studies, whereas Institutional Review Boards (IRBs) have oversight responsibility for non-significant risk studies.
On October 26, 2002, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) was signed into law. Among other things, MDUFMA amends the Federal, Food, Drug, and Cosmetic Act (the Act) by adding several new provisions intended to promote the development of safe and effective pediatric devices and to protect this vulnerable patient population during the course of clinical trials involving such products. This guidance, as well as a collateral guidance on procedures for ensuring that pediatric expertise is available to FDA Advisory Panels when appropriate[1], will help the agency achieve the intent of the pediatric provisions of MDUFMA.
[1] “Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff” can be found at http://www.fda.gov/cdrh/ode/guidance/1208.html.
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