![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 Spells Out Policy and Considerations for Multiple Function Devices
FDA Spells Out Policy and Considerations for Multiple Function Devices
![FDA_Logo_Black_2016.gif](https://www.fdanews.com/ext/resources/test/Drug-Images4/FDA_Logo_Black_2016.gif?t=1579040596&width=430)
May 2, 2018
The FDA recommended factors to consider and precautions to take for premarket submissions of multiple function device products, noting there is no all-encompassing approach for the wide variety of multiple function devices.
The guidance defines the term “function” as a medical device product’s distinct purpose, such as its intended use. For example, a product whose intended use is to analyze data has a single function: analysis. A product with intended uses to store, transfer and analyze data has multiple functions: storage, transfer and analysis.
The device function under review should be separated from other device functions “in its design and implementation,” the agency said.
Upcoming Events
-
21Oct