PMA Supplement Guidance Finally Finalized, But Questions Remain
This article was originally published in The Gray Sheet
Executive SummaryFDA 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11 explaining what PMA supplement submissions are required for certain product modifications, largely mirroring 2007 draft guidance that device makers considered "incomplete.
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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.