PMA Supplement Guidance Finally Finalized, But Questions Remain
This article was originally published in The Gray Sheet
Executive Summary
FDA finalized guidelines Dec. 11 explaining what PMA supplement submissions are required for certain product modifications, largely mirroring 2007 draft guidance that device makers considered "incomplete.
You may also be interested in...
FDA Manufacturing-Change Reviews Will Shift From Compliance Office To ODE
The move is in line with the agency’s intention to focus on the total product life-cycle, such that the same staffers that review an original marketing submission will look at the safety and effectiveness of manufacturing changes.
PMA Parallels
Harvard cardiologist and device safety expert William Maisel sees a parallel "loophole" in FDA's model for assessing modifications to existing PMA products, which he says allows too many products on the market by means of a PMA supplement, which is less rigorous than a full PMA application.
Edwards’ Mitral Valve Repair Device Withdrawn, Under Scrutiny
Edwards Lifesciences removed a mitral valve repair device from the market in October and submitted a 510(k) for the product in the midst of an FDA inquiry into whether the device was being marketed without proper clearance