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11 explaining what PMA supplement submissions are required for certain product modifications, largely mirroring 2007 draft guidance that device makers considered "incomplete.You may also be interested in...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
Edwards’ Mitral Valve Repair Device Withdrawn, Under Scrutiny
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