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smitshah replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 7 years, 8 months ago
FDA need to be rigid and strict in order to make sure that good quality products are launched which in any way does not harm people on use, because they are someone who are trusted by so many people with there life. I would also agree that the way FDA approval procedures are laid that is somethings that takes long for approval. If FDA tries to restructure the approval process and to some extent simplify the process this would increase the number of product approved and also make sure the products that are launched are also safe.So I think the barrier between the safe and sound product and rate at which they are approved is something which can be diminished by simplifying and restructuring the procedure.
In order to prove my point I would like to co relate toxicity table. What if you have a implant ready and you forget to do or think that Genotoxity test in it is not important just on the fact that its not necessary. But things like this would not happen if FDA comes into picture and if they have enough power. So i think FDA has been great in its jobs its just that it need some changes to make it a win-win situation for both manufacturer and also for consumers.