Medmarc Blog (blog.medmarc.com)
AI
FDA Unveils Upgrades for the Agency’s Elsa AI Agent
The FDA has upgraded its Elsa artificial intelligence (AI) agent, which is now on its fourth iteration in less than a year. The upgrade comes with the integration of a data platform that will...
FDA Overhauls Guidance for Clinical Decision Support
The FDA’s Center for Devices and Radiological Health has reissued its guidance for clinical decision support (CDS) software in a rewrite that significantly relaxes the regulatory qualifications for...
FDA Product Centers Collaborate on AI Draft Guidance
The U.S. FDA posted a draft guidance for AI-enabled device software functions (DSFs) in January 2025, which provides much-needed clarity for a number of product types. All three of the agency’s...
AI Regulation Lagging Behind Innovation and Creating Friction
Developers of artificial intelligence (AI) products have moved quickly into a wide range of product types, but regulatory agencies are struggling to keep pace. One of the issues for industry is that...
Evolving Labels and Warnings for AI-Enabled Devices: Managing Risks
When FDA finalized its guidance on Predetermined Change Control Plans (PCCPs) and, shortly after, joined Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in...
FDA Guidance on AI Medical Devices: Predetermined Change Control Plans
One of the challenges regulators face with AI-enabled medical devices is that they are not static products. Unlike a traditional implant or diagnostic tool, the device that receives FDA approval may...
FDA Finalizes Guidance for AI Predetermined Change Control Plans
The FDA has published the final version of a guidance for predetermined change control plans (PCCPs) for artificial intelligence (AI) software. The final guidance is limited in terms of scope, but...
FDA Appoints New Director for Center for Devices
The FDA has appointed a new director for the Center for Devices and Radiological Health (CDRH) to replace Jeff Shuren, who has been at the helm of CDRH since 2009. Michelle Tarver has taken over as...
Mammography False Positives Endanger Screening Compliance
A new study published recently in the Annals of Internal Medicine disclosed an association between false positive results on mammography screening exams and a reluctance to return for screening....
Regulatory Partners Release guidelines for PCCPs
The FDA and two other national regulatory agencies have collaborated on a set of guiding principles for predetermined change control plans, or PCCPs, which are applicable to machine learning-enabled...