By Christopher Latoz, M.S., Hollister Incorporated, Laure Larkin, M.S.., Ethicon Inc, and Kim Huynh-Ba, M.S., FAAPS, Pharmalytik Consulting LLC
Introduction
In July 2013, 21 Code of Federal Regulations (CFR) Part 41 went into effect to establish the good manufacturing process (GMP) rules that apply to combination products. These therapeutic and diagnostic products may consist of two or more of the following: drug, biologic, and device. The FDA issued additional guidance in 20172 to streamline the regulatory framework around demonstrating GMP compliance when there are multiple regulatory standards for combination products: single entity and co-packaged. Co-packaged combination products are two or more separate products stored in a single package or together as a unit. In contrast, single-entity products comprise two or more regulated components (i.e., drug-device, biologic-device) that are physically, chemically, or otherwise combined.
Drug-eluting stents and transdermal nicotine patches are two common examples of single-entity combination device products. In contrast, surgical kits containing drug and device constituents, such as a vial containing a drug product and a separate dispensing device, are co-packaged. Over the years, more and more drug and device manufacturers have become interested in developing combination devices, though many lack in-depth knowledge and expertise in the non-primary regulations. Let us begin by considering the case of a drug manufacturer that desires to bring a drug-device product to market.