US regulatory compliance for medical combination products: an overview - Singh, Manav V.; Apshingekar, Prafulla; Gandhi, Sanyam; Singh, Om V. (Frontiers in medical technology, 2024)
Keywords: combination products (CP); Food and Drug Administration (FDA); medical device; Medical Technology; Office of Chief Counsel (OCC); Office of Combination Products (OCP); Request for Designation (RFD); regulations; Office of Chief Counsel (OCC); Office of Combination Products (OCP); Food and Drug Administration (FDA); Request for Designation (RFD); medical device; Federal Food Drug and Cosmetic Act (FFDCA); combination products (CP)