510(k) Guidance Overhauls U.S. FDA’s Risks vs. Benefits Review Process

International Medical Device Regulatory Monitor
A A
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of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week.

To View This Article:

Login

Subscribe To International Medical Device Regulatory Monitor

Buy This Article Now

Add this article to your cart for $40.00