Home > Newsletters > Devices & Diagnostics Letter > Industry Seeks More Clarity on 510(k) Refuse-to-Accept Draft Guidance
Devices & Diagnostics Letter
Oct. 15, 2012 | Vol. 39 No. 41
Industry Seeks More Clarity on 510(k) Refuse-to-Accept Draft Guidance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.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.