JD Supra

Medical Device Update: FDA Publishes Three New Guidance Documents for the 510(k) Premarket Notification Program

The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket ...
Healio

'Meaningful percentage' of approved orbital implants based on recalled predicate devices

Please provide your email address to receive an email when new articles are posted on . Some currently marketed orbital implants were cleared through equivalence to a later-recalled device, according ...
JD Supra

FDA fills 510(k) guidance gaps with drafts on predicate devices, clinical data, implantables

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products ...