U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) has published a draft guidance intended to...

As part of its effort to streamline the process for reporting malfunctioning medical devices,...

The U.S. Food and Drug Administration (FDA) has launched a new pilot program intended...

The U.S. Food and Drug Administration (FDA) is seeking public comment on a proposed...

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The FDA has published a draft guidance to clarify its requirements and review practices in connection with medical device applications submitted under its Humanitarian Device Exemption (HDE)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