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jr377 replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 6 years, 10 months ago
I believe that “There is no such thing as a free lunch” is a really applicable quote for this situation. As stated previously stated, there are costs to hiring people to create and maintain this standard. All of the work put into the standard, including the test that the standards exemplify, require money. There are also basic costs that, for example, the FDA has to consider such as website maintenance and general budgetary needs. Those costs would go directly to taxpayers, most of whom don’t actually use these standards. Having these standards cost money allows them to recoup some money while allowing people to buy individual standards. For smaller companies and startups, I believe that a good alternative would be charging either a smaller price per standard until they produce a product or doing a “buy x get x free” system. They could have to pay the rest of the money owed when they start making money. I don’t believe they should get stuff for free, especially if they succeed. Although big companies can afford it, it’s not fair to them to charge only them.