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 Part 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, will help the agency achieve the intent of the pediatric provisions of MDUFMA.
This guidance should be used in conjunction with other device-specific guidances to help ensure that medical devices intended for use in the pediatric population provide reasonable assurance of safety and effectiveness.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.