How to Make Sure You Are Prepared and Ready with All Information Needed for a Medical Device Premarket Notification Submission to FDA.
The FDA 510(k) Process: Improving Your Odds of Success and Shortening Approval Time
Covered in this paper:
-
How to approach the FDA 510(k) approval process
-
How the process works
-
Predicate device research
-
Identifying the right product code