fda

FDA device clearance times remain lengthy—averaging 140–175 days, far beyond the 90-day goal. Staffing cuts and process shifts fuel delays, while underused third-party review programs offer a potential shortcut for manufacturers seeking faster approvals.

The U.S. Food and Drug Administration (FDA) has now rescinded 2024 rules that required laboratory-developed tests (LTDs) to comply with the agency’s pre-marketing authorization requirements applicable to medical devices.

The U.S. Food and Drug Administration (FDA) has recently updated its list of medical devices that have received market authorization under its Breakthrough Devices Program.

The U.S. Food and Drug Administration (FDA) has released data that it says affirms the safety of certain per- and polyfluoroalkyl substances (PFAS) used in medical devices.

The U.S. Food and Drug Administration (FDA) has reportedly sent warning letters to several medical device manufacturers for violations of its device marketing and good manufacturing practices requirements.

The U.S. Food and Drug Administration (FDA) has announced a new initiative to support the more efficient development of digital health devices.

The U.S. Food and Drug Administration (FDA) is already encountering implementation issues with its efforts to leverage the potential benefits of AI-based technologies.

The use of artificial intelligence (AI) tools is rapidly gaining traction throughout industries around the world. Now, the U.S. Food and Drug Administration (FDA) is stepping up to leverage the potential benefits of AI.

The U.S. Food and Drug Administration (FDA) is stepping up its use of unannounced inspections at foreign manufacturing facilities that produce medicines and other medical products.

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.