fda

The U.S. Food and Drug Administration (FDA) has announced user fees applicable to medical...

The U.S. Food and Drug Administration (FDA) is seeking public comment on an updated version of its proposed pilot program to speed the approval of software used in digital health applications.

The FDA has published a draft guidance to clarify its requirements and review practices in connection with medical device applications submitted under its Humanitarian Device Exemption (HDE) Program.

The FDA has issued a Final Order that exempts certain Class II medical devices from the agency’s premarket notification (510(k)) requirements.

The FDA has published an updated list of recognized consensus standards that can used in support of premarket medical device reviews conducted by the agency.

In an effort to harmonize its medical device quality management system regulations with globally-accepted...

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance intended to clarify its policy regarding the assessment of medical devices offering multiple functions.

The FDA has released a draft guidance that may help reduce the burden on device manufacturers seeking to demonstrate substantial equivalence for some types of new medical devices.

The FDA has issued a draft Guidance on transferring a premarket notification (510(k)) clearance from one person to another.

The U.S. Food and Drug Administration (FDA) has warned the manufacturers of duodenoscopes of their obligation to conduct post-market surveillance studies to assess the effectiveness of post-use decontamination protocols.