FDA Devises Flow Chart to Guide 510(k) Evaluations

Devices & Diagnostics Letter
Concerns about the future of the FDA’s 510(k) process appear to have been put to rest with the year-end issuance of a draft guidance on evaluating substantial equivalence in 510(k)s.

To View This Article:


Subscribe To Devices & Diagnostics Letter

Buy This Article Now

Add this article to your cart for $25.00