This guidance is part of FDA's overall review of the 510(k) process, which is expected to culminate later this week with recommendations from IOM:
FDA's 510(k) Guide Could Mandate Off-Label Use Listing, Impact Practice Of Medicin - Inside Health Policy: "FDA's new policy outlining when 510(k) clearance applications are necessary for modified medical devices reverses the agency's stance of not requiring submissions when adding home use indications to labels and delves into the practice of medicine by requiring manufacturers to factor potential off-label uses into their design changes, an industry attorney said. The policy -- outlined in a guidance document released Tuesday (July 26) -- is part of the agency's plan to revamp the 510(k) process, with a highly anticipated Institute of Medicine report due out Friday (July 29) that is expected steer how the agency reforms the device clearance pathway."
