510(k)

The FDA opens the books on how its accredited third-party reviewers are performing under the 510(k) pathway, revealing review times that stretch well beyond agency averages in some cases. The data offers device makers a rare look at where third-party review speeds up, and where it stalls, market access.

The FDA has finalized its guidance on human factors information required in medical device marketing submissions, outlining a risk-based framework for 510(k)s, PMAs, De Novo requests, and HDE applications. Here's what manufacturers need to know before their next premarket submission.

The FDA has updated its list of more than 1,700 recognized voluntary consensus standards used to demonstrate compliance in medical device premarket submissions. Find out which specialties are covered and how declarations of conformity can streamline your path to market authorization.

New FDA data shows more than 1200 medical devices have now been granted Breakthrough Device designation. With 164 approvals in fiscal year 2025 and continued strong activity across CDRH and CBER, the program remains a key pathway for accelerating innovative medical technologies.

The U.S. Food and Drug Administration (FDA) has released its final guidance on premarket...

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

The U.S. Food and Drug Administration (FDA) has issued an updated guidance to explain...

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

The U.S. Food and Drug Administration (FDA) has issued a draft guidance to further...