Articles & Regulatory News
Curated regulatory news and ESL briefs on FDA-authorized AI medical devices: recall system concerns, the 510(k) pathway, generative AI regulation, and software verification enforcement trends.
FDA Device Recall Problems Raise Questions About Patient Safety, Clinician Liability
Medscape Medical News examines how persistent problems in the FDA device recall system raise questions about patient safety and clinician liability. The report traces the issue back to the 510(k) pathway: although it began as a loophole, a 2023 study found that about 99% of devices cleared for market went through it, and it asks what clinicians can do when recalled devices keep reaching patients.
Summary republished with credit. Original article by John McFarland, Medscape Medical News, October 6, 2026. Full article © Medscape; read the original on medscape.com.
Read on the source site →Static Code Analysis Alone Is Not Enough: Add Unit Testing & Code Coverage
Seven FDA enforcement cases show one consistent pattern: teams that passed system-level testing and managed static-analysis findings were still cited for missing code-level verification. The brief maps each case to the exact ESL solution with Parasoft tools.
Read the article →FDA seeks feedback on regulating Generative AI-enabled medical devices
FDA issued a discussion paper and request for feedback on considerations for the regulation of generative AI-enabled medical devices. Public comments are open through October 19, 2026.
Read on the source site →