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510(k) vs De Novo vs PMA: Which FDA Pathway Fits Your AI Medical Device?
Compares the FDA's three primary medical device marketing pathways—510(k), De Novo, and PMA—explaining when each pathway applies, the evidence required, and how AI medical device companies can determine the appropriate regulatory route. The FDA generally uses 510(k) for substantially equivalent devices, De Novo for novel low-to-moderate-risk devices without a predicate, and PMA for high-risk Class III devices.
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