FDA’s newly published final guidance on Multiple Function Device Products: Policy and Considerations explains its policies and regulatory practices for devices that have an additional “other function” not the subject of a premarket review, reports MedTech Dive.
The guidance clarifies how the agency intends to assess the impact of those other purposes on the safety and effectiveness of a device function that is under FDA’s review.
FDA published the draft version of the guidance in April 2018. The agency said it incorporated feedback in the final guidance from public comments to clarify and provide examples describing the application of its policies on products with multiple functions. AdvaMed, BD and GE Healthcare were among the industry voices that weighed in.
In its final guidance, FDA provided seven examples of multiple-function device products to illustrate how assessment of an “other function” would impact a product function under review. The hypothetical examples included a skin cancer detection software application, hand-held coagulation device, a product that determines traumatic brain injury, and a pain treatment app.
Read the full story at MedTech Dive.