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The U.S. Food and Drug Administration has issued updated guidance on cybersecurity requirements for medical device premarket submissions, aligning more closely with current quality management system standards, emphasizing lifecycle risk management, and encouraging manufacturers to adopt secure product development frameworks.

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. Department of Health and Human Services will launch a new study examining potential health effects of cellphone radiation, following the FDA’s removal of older web pages on the topic. The review aims to clarify scientific gaps amid evolving wireless technologies.

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The U.S. Food and Drug Administration (FDA) has now rescinded 2024 rules that required laboratory-developed tests (LTDs) to comply with the agency’s pre-marketing authorization requirements applicable to medical devices.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