FDA has a target review of 90 days per module and 180 days after the final
module
Useful for devices at an early development stage
What is a PDP PMA? - ✔✔Used for well known technologies
...
PMA supplements can be used for? (7) - ✔✔1. New indication for use
2. Labeling changes
3. change in ..
, If change to a PMA after approval, but does not impact safety effectiveness? -
✔✔annual report
What is the difference between a PMA supplement vs amendment? -
✔✔PMA supplement is after the PMA is approved and changes are made
PMA amendment is additional information during review of a PMA or a PMA
supplement
Panel Track Supplement - ✔✔Design or performance change, add a
new indication for use.
Clinical data required
Subject to full review
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