Recent FDA Draft Guidance to Industry Offers Insight on "Content of Premarket Submissions for Device Software Functions" | Arnall Golden Gregory LLP
Recently, the Food and Drug Administration issued a draft guidance, “Content of Premarket Submissions for Device Software Functions,” to help industry understand what it should include...
Software Design Specification Premarket Submissions For Device Software Functions Software Requirements Specification Drug Administration Premarket Submissions Device Software Functions
Source: jdsupra.com