510(k)

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The U.S. Food and Drug Administration (FDA) has issued a draft guidance to further...

The U.S. Food and Drug Administration (FDA) now has a secure web-based tracking system...

The U.S. Food and Drug Administration (FDA) has issued a final guidance clarifying the...

Despite the month-long partial shut-down of the U.S. federal government, the Food and Drug...