U.S. Food and Drug Administration (FDA)

FDA Updates Authorizations List for Breakthrough Devices Program

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.

FDA Confirms That Use of Certain PFAS in Medical Devices is Safe

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.

FDA Issues Warning Letters for Violations of MedTech Marketing and Good Manufacturing Practices Regulations

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.

FDA Launches Regulatory Accelerator for Digital Health Devices

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

FDA’s New AI Tool Struggles with Basic Tasks

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.
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FDA to Expand Use of AI in Scientific Reviews

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.

FDA Expands Unannounced Inspections of Foreign Manufacturing Facilities

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.

FDA to Address Data Integrity Concerns with China-Based Third-Party Testing Labs

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.

FDA to Phase Out Animal Testing Requirements for Drugs

The U.S. Food and Drug Administration (FDA) reports that it is taking action to reduce or eliminate animal testing in the development of certain categories of drugs and other medications.

T-Mobile to Test Nokia’s 6G Equipment

U.S. cellular service provider T-Mobile has reportedly received permission from the U.S. Federal Communications Commission (FCC) to conduct experimental testing of equipment using 6G technology.
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