Hyman Phelps and McNamara Hyman Phelps and McNamara
Product Jurisdiction and Combination Products
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Given the fast pace of technology and corresponding range of novel therapies under development today, HPM is frequently called upon to ascertain how new products, or existing products with new features, will be regulated. In some cases, the determination involves the jurisdictional boundary between FDA and another agency, such as the Consumer Product Safety Commission (e.g., exercise equipment) or the Environmental Protection Agency (e.g., antimicrobial agents with both food and industrial applications). In other cases, the determination involves the jurisdictional boundary between the various centers at FDA (i.e., CDER, CBER, CDRH, or CFSAN). HPM has assisted numerous companies with the development of such combination products and strategies for obtaining approval. HPM attorneys assist with filing requests for designation and advise companies on the relevant considerations with respect to primary jurisdiction by the different FDA centers.


Primary Contacts:

Jeffrey Shapiro

Jeffrey Gibbs

Robert Dormer


Developments in the Law