FDA has issued a draft guidance to clear up its policy for products that have more than one function. The draft, Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff, is related to Digital Health and the 21st Century Cures Act. It suggests that when assessing a product that has multiple functions, manufacturers and the FDA should assess whether any other function could affect the safety and effectiveness of the device function under the agency’s premarket review.
“The FDA recommends that when possible, the device function under FDA’s premarket review should be separated from other functions of the device, and that the higher the degree of separation, the easier it is for the agency to independently review it for safety and effectiveness.” – FDA
The intent of the guidance is to clarify when and how the agency expects to look at the affect of other device functions that aren’t the subject of a premarket review on the safety and effectiveness of a device function that is subject to FDA review. The draft aims to identify principles, premarket review practices and policies for the agency’s regulatory assessment of these types of products and to also provide some application examples.
Industry can submit comments on this draft guidance until June 26.