Content of Premarket Submissions for Device Software Functions guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Discover more from सुदर्शन
Subscribe to get the latest posts sent to your email.