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cjm64 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
The balance between safety and speed through the system is something that is hard to balance, and whilst I think the process takes too long I would much rather a system that takes longer but makes sure that the products that are released are safe, rather than have a system where things can get cleared faster but might be unsafe.
There are other factors that are major downsides too. The elongated approval time means that only companies that can sustain themselves with other income sources whilst products are being approved are able to get products through. This leads to only large companies being able to do it which can cause stagnation in terms of innovation. I also think this creates a different mentality within the industry. Many startups know the only way that they can get their product to market is to either have angle investors willing to gamble on the company or to get bought out by a larger company.
I don’t think the balance it right currently but I don’t know if there are any changes that can be made that will decrease approval time without putting the consumer in danger.