Main Article Content
All healthcare goods in the pharmaceutical sector are classified as Drugs, Devices, and Biologics, and they are governed by their respective regulatory authorities. In the current context, Science and technological advancements have led to the development of innovative novel items in the healthcare sector. More accurate illness identification and treatment, as well as the growth of these revolutionary technologies, have resulted in a blurring of the lines. Due to historical distinctions between healthcare products, these developments gave rise to products with merged features. A regulation about combination products and the FDA's perspective. The article discusses guidelines regarding the combination product and what are the challenges that occur to regulate combination products
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Principles of Premarket Pathways for Combination Products
Post marketing safety reporting for combination products https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products
How to request Pre-RFD