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  • Mirna Cheikhali replied to the topic "Pre-market Approval (PMA) vs. 510(k)"2 months ago

    The FDA approves medical devices through two main pathways: PMA for high-risk Class III devices, requiring extensive clinical testing, and 510(k) for moderate-risk Class II devices, which must show similarity to an existing product. PMA is rigorous, costly, and time-consuming,…   Read more»