![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA, UK Adjust Combination Product Determination Process
FDA, UK Adjust Combination Product Determination Process
![](https://www.fdanews.com/ext/resources/test/Drug-Images3/StackofFolders.gif?t=1433943470&width=430)
FDA officials said the agency will allow earlier interaction with sponsors to determine the regulatory pathway for combination products. In a similar move, the UK issued updated guidance to help sponsors make those determinations.
Previously, devicemakers would submit a Request for Determination to the FDA’s Office of Combination Products to help them make decisions about whether the agency would regulate the combination product as a drug or device.
Manufacturers can now engage FDA officials earlier in the process under a Pre-Request for Designation process, which will allow them to make decisions earlier in the product development cycle. — Tamra Sami
Upcoming Events
-
21Oct