fda

The FDA has finalized its guidance on human factors information required in medical device marketing submissions, outlining a risk-based framework for 510(k)s, PMAs, De Novo requests, and HDE applications. Here's what manufacturers need to know before their next premarket submission.

The FDA has updated its list of more than 1,700 recognized voluntary consensus standards used to demonstrate compliance in medical device premarket submissions. Find out which specialties are covered and how declarations of conformity can streamline your path to market authorization.

The FDA is inviting medical device developers to participate in the READI-Home Innovation Challenge, seeking proposed solutions for home-use medical technologies that reduce hospital readmissions, with selected participants receiving direct regulatory feedback to refine their designs.

The FDA has finalized guidance on premarket submission requirements for weight loss medical devices, covering non-clinical testing, clinical study design, and benefit-risk analysis. Developers of intragastric implants, aspiration therapy systems, and neuromodulators will want to review the agency's recommendations closely.

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The U.S. Food and Drug Administration (FDA) has now rescinded 2024 rules that required laboratory-developed tests (LTDs) to comply with the agency’s pre-marketing authorization requirements applicable to medical devices.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