CDRH

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) is raising concerns about the integrity of data submitted by two China-based testing laboratories in support of recent premarket medical device submissions.

The Center for Devices and Radiological Health at the U.S. Food and Drug Administration has published an extensive list of guidance documents that it intends to publish or develop in fiscal year 2025.

The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has announced the expansion of its program intended to foster more efficient and expeditious development of innovative medical devices.