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puneet replied to the topic 510(k) clearance vs. Postmarket Approval in the forum Introduction to Project Management 7 years, 2 months ago
I agree that it would be unethical for a company to embellish their product to try to get it classified as a type II device rather than a type III device because of the large risk associated with class III devices. The company runs the risk of negative affects from their device if it hasn’t been properly tested for its proper classification. Without proper testing an unsafe device can end up on the marker which could result in severe consequences. I also think it would be in the company’s best interest not to embellish the product in the first place because it also runs the risk punishment by the FDA if figured out.