Regulatory Prospective about Combination Products in USFDA
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
Requesting FDA feedback on combination products. FDA. s.l.: U.S department of health and human serices, 2020.
Uemura N, Kasanuki H, Umezu M. New Visualization Models of Designation Pathway and Group Categorization of Device-Drug and Device-Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions. Ther Innov Regul Sci. 2021 Jul;55(4):807-817. doi: 10.1007/s43441-021-00276-x. Epub 2021 Apr 12. PMID: 33844189; PMCID: PMC8238755.
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