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sahitya.sadineni replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 7 years, 6 months ago
Regulations are very important to any company because the products have to follow a certain standard for safety. Some people may argue that it is unfair but the FDA does a really good job to ensure the standards are followed and they should be paid to make sure this is done properly. All documentation should be paid if not, anyone can access it also. If it goes into the wrong hands, it would liable for the company because all of their work is now accessible to the public. But the document should be paid once but every time a revision is made, the company should not need to pay for it.