FDA regulatory requirements for products are heavily influenced by the product’s classification. FDA has developed procedures for determining whether a product should be regulated as a drug, device, or biologic. Understanding FDA’s procedures for determining jurisdiction is essential for companies that are seeking to market a product where it is not clear which category the product falls into or which Center will regulate it. Unfortunately, FDA’s own procedures for establishing jurisdiction are themselves not clear and can lead to unexpected outcomes. In a new article in FDLI’s Update Magazine, titled "FDA and Product Jurisdiction: Time for Reforms," Hyman, Phelps & McNamara, P.C., Director Jeffrey N. Gibbs discusses the FDA jurisdictional process and some of its challenges.
Reminder: Register now for the May 3, 2016 Virginia Tech and HP&M Conference on Effective Documentation. Information on the conference is available here.