Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

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 Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...

FDA's digital advisors could nudge the agency to clarify how its rules apply to medical applications of generative AI, including therapy chatbots.

The FDA’s firm-based approach to regulating medical devices means that the regulatory oversight focuses on the quality systems and processes of the manufacturing firm, rather than just on the ...

FDA announcement of the creation of a Digital Health Advisory Committee causes a 7.2% decline in the iShares U.S. Medical Devices ETF. Digital health industry shows immense potential, driven by ...

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 ...

The US Food and Drug Administration (FDA) is seeking industry comment on practical approaches towards measuring and evaluating the performance of AI-enabled medical devices in the real world. With a ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

The past couple days of following the House Energy and Commerce Subcommittee hearings on mobile health regulation has forced me to clarify my thinking about regulation of this sector. Since the US ...