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Home » 510(k) Guidance Overhauls U.S. FDA’s Risks vs. Benefits Review Process
510(k) Guidance Overhauls U.S. FDA’s Risks vs. Benefits Review Process
For the first time, manufacturers submitting 510(k)s would have to show U.S. Food and Drug Administration reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week.
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