FDA Spells Out Policy and Considerations for Multiple Function Devices

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.

View today's stories