The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more
This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more
The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more
On the same day the Food and Drug Administration issued its revised draft guidance document on when to submit a new 510(k) premarket notification for an existing medical device, it released a similar document specific to...more
FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft...more