The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases.”
The purpose of the workshop is to discuss issues related to the following broad topics associated with medical devices for the diagnosis and treatment of pediatric patients affected by rare diseases: Current approaches toward use of medical devices for pediatric clinical practice; Humanitarian Device Exemption (HDE) marketing pathway, including the Humanitarian Use Device (HUD) designation process; Pediatric Specialty-Specific Practice Areas; Clinical Trials; Registries; Pediatric Needs Assessment; and Possible Approaches to Advancing Pediatric Medical Device Development. FDA is seeking input from these topics from academicians, clinical practitioners, patients and advocacy groups, industry, and governmental agencies.
Contact: Tomeka Arnett, 301-796-2500; email: [email protected]