U.S. Food and Drug Administration (FDA)

The FDA opens the books on how its accredited third-party reviewers are performing under the 510(k) pathway, revealing review times that stretch well beyond agency averages in some cases. The data offers device makers a rare look at where third-party review speeds up, and where it stalls, market access.

A new Senate bill could require cybersecurity reviews and even mandatory recalls of Chinese-made medical devices already deployed across U.S. healthcare systems. Find out what the proposed Countering CCP Act could mean for manufacturers, providers, and patient safety in the months ahead.

The FDA trims its shortage list to just a handful of devices, while quietly flagging over 140 products manufacturers are discontinuing this year. See which device categories made the cut and what it signals for supply availability.

The FDA has expanded its list of medical devices exempt from premarket notification, easing the regulatory path for manufacturers across several product categories. The updated guidance touches everything from hearing protectors to diagnostic test strips — with real implications for how quickly new devices can reach market.

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.

The FDA has refreshed its list of recognized standards, adding new cybersecurity‑focused health‑informatics standards and updated materials tests used in medical devices. The latest changes signal where regulators are heading—and what manufacturers will need to show in future submissions.