Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff
Submitted by kBLASTER Team on
This FDA guidance document published on July 13, 2012 is being distributed for comment purposes only and contains nonbinding recommendations.
The following excerpt from the guidance document applies specifically to the issue of predicate selection:
2. Content of a Pre-Sub for a 510(k)
The Pre-Sub should contain sufficient information for FDA to provide advice to your specific questions. In addition to the information suggested in Section III of this guidance,...