FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...

Opinion: Companies developing AI-enabled health-care technologies should treat regulatory and IP strategies as parallel, ...

Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...

FDA clearance is a vital milestone for ASX medical device companies, opening access to the US market while navigating the regulatory process.

The letter, dated Sept. 9, was issued by the Center for Devices and Radiological Health. It follows inspections of Philips Ultrasound facilities in Bothell, Wash. and Reedsville, Pa., as well as a ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

U.S. Senator Michael Bennet (D-Colorado) is urging the FDA to choose medical device regulatory reforms that will simplify manufacturing processes, according to a news release from Sen. Bennet. In a ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...

In a letter to Philips’ CEO, the FDA cited quality system issues at three of Philips’ manufacturing sites, and failures over ...

The collaboration will facilitate the provision of secure over-the-air software updates for connected devices.