View Cart  

Industry Seeks More Clarity on 510(k) Refuse-to-Accept Draft Guidance

Devicemakers praised FDA efforts to craft guidance on the agency’s refuse-to-accept policy for 510(k) premarket notification submissions, but took issue with many specifics, including what would happen if a backlog causes the FDA to miss its proposed 15-day timeline.

To View This Article:


Subscribe To Devices & Diagnostics Letter

Buy This Article Now

Add this article to your cart for $25.00