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Home » Draft Guidance on Stent Testing Fails to Eliminate Unneeded Tests
Draft Guidance on Stent Testing Fails to Eliminate Unneeded Tests
October 25, 2013
The FDA’s draft guidance on certain nonclinical intravascular stent tests clarifies agency expectations for corrosion testing, but does not provide enough advice on the levels where harm could be significant and fails to eliminate unnecessary tests, devicemakers say.