title: A Roundtable Discussion: Combination Products: Twice the Challenge?
abstract: Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and/or biological products with one another. FDA developed a regulation (final rule) on Current Good Manufacturing Practices (CGMP) for combination products that became effective July 22, 2013 (21 CFR Part 4). AAMI recently developed a technical information report (TIR) that provides information on how to effectively implement FDA's regulation. The overall goal of the TIR is to aid informed, risk-based decisions in establishing CGMP operating systems that support development, manufacture, premarket regulatory evaluation, and ultimately commercialization of combination products. This article, a result of an discussion with industry and FDA representatives, explores the landscape of combination products, highlights important considerations in developing and seeking marketing clearance for these innovative products, and provides insight on trends in the area.
authors.forename: Nolan
authors.initials: N
authors.lastname: Baird
authors.forename: Steven B
authors.initials: SB
authors.lastname: Binion
authors.forename: Jon
authors.initials: J
authors.lastname: Cammack
authors.forename: Stephanie Del
authors.initials: SD
authors.lastname: Paine
authors.forename: Rosemary
authors.initials: R
authors.lastname: Gonzales
authors.forename: Jena
authors.initials: J
authors.lastname: Passut
authors.forename: John Barlow Barr
authors.initials: JB
authors.lastname: Weiner
mesh_terms: D003657:Decision Making; D018795:Device Approval; D004059:Diffusion of Innovation; D017277:Drug Approval; D006804:Ergonomics; D006801:Humans; D040541:Marketing; D012308:Risk Management; D014481:United States; D014486:United States Food and Drug Administration