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RyanRattazzi replied to the topic 510(k) clearance vs. Postmarket Approval in the forum Introduction to Project Management 6 years, 8 months ago
This is a good question, that I wondered myself. It seems that there is a significant advantage in the timeline of developing a product if a product is labeled as class 2 rather than class 3. For products that have the risk factor of class 3, but are granted class 2 classification due to the fact that a similar product has been on the market seem to have a lot to gain from stretching the truth about how similar they actually are to another product in order to pass on inspections and clinical tests. However, this would be both hard to do in the first place, and could also drastically backfire on the company if there was to be a safety issue or recall on the product due to the lack of inspection and testing done in pre-market. For this reason, I think there is no need to adjust the classification system.