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 ...
JD Supra

FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications

The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.” This ...
STAT

FDA proposes changes to key approval pathway for medical devices, five years after promising

Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the Food and Drug Administration has issued new guidelines to improve its so-called 510(k) ...
BioWorld

US FDA wary of predicate devices in draft guidance for jawbone grafts

Upgrade your daily dose of biopharma and medtech news Subscribe to BioWorld™ news services See subscription options To read the full story, subscribe or sign in. US FDA wary of predicate devices in ...
BioWorld

US FDA wary of predicate devices in draft guidance for jawbone grafts

The U.S. FDA issued a draft guidance for premarket applications for class II bone grafting devices, a policy that would supplement a guidance issued nearly two decades ago.