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James Saleh replied to the topic "What are challenges will we face if we missclassify a medical device ?" – 5 months ago
One major issue is regulatory noncompliance. Each device class (I, II, III) has different FDA requirements for testing, documentation, and approval pathways such as 510(k) and PMA pathway. If a device is classified too low, it may bypass necessary preclinical… Read more»
