Modernizing the FDA's 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 2
December 19, 2018
By Alex Butler, Manager of Medical Device Solutions, MasterControl
This is Part 2 of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. This blog post discusses the pros and cons of the program in general and the dangerous loophole in the equivalence approach.
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