The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

Is AI the solution to America’s glacial drug approval process, or a Pandora’s box for public health? That’s the question ...

While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency. In fact, the FDA’s definition of a ...

The FDA is notifying healthcare providers about import alerts for certain medical devices manufactured in Japan by Olympus.

Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...

The Food and Drug Administration has published final guidance for the cybersecurity of premarket medical devices. The new ...

Califf completed his second term as FDA commissioner in January with the change in administrations. He’s only the second ...

The Food and Drug Administration is urging medical product makers to carefully address the cybersecurity of their connected ...

The FDA has barred the import of multiple medical devices manufactured by Olympus Medical Systems and its subsidiaries in Japan, citing ongoing violations of federal quality system regulations.