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 AHA is calling for a framework that balances innovation with appropriate safeguards to protect privacy and patient safety ...

December 1, 2025Sara Brenner, M.D., MPHPrincipal Deputy CommissionerU.S. Food and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993Submitted ElectronicallyRE: FDA-2025-N-4203 Request ...

The American Hospital Association is urging the FDA to revise the current framework for AI-enabled medical device clearance by pursuing risk-based post-deployment standards and other measures. In a ...

The FDA’s cybersecurity dictates around premarket applications’ have been in effect since 2023, with more post-market ...

According to DataM Intelligence, the U.S. Software as a Medical Device (SaMD) Market Size reached USD 205.12 million in 2024 and is forecast to climb to USD 715.00 million by 2033, expanding at a ...

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, ...

The FDA recently issued draft guidances for the use of AI in medical devices, drugs, and biologics. The guidances emphasize the need for comprehensive AI policies addressing risk evaluation, data ...

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...

(I would like to thank John Murray of FDA, Scott Thiel of Roche Diagnostics and Russ Gray of the Anson Group for their comments on a draft. The views expressed -- right or wrong -- are only the author ...