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    merzkrashed replied to the topic "Discussion Topic: Revamping the 510(k) Process" – 5 years, 10 months ago

    Here another example: No More 510(k)-only PMA required for all Automated External Defibrillators (AEDs) FDA has finalized a change in policy that will soon require all Automated External Defibrillators (AEDs) to undergo a more rigorous regulatory review process meant to…   Read more»