Signal of the Day · Regulation & Policy
FDA declines to exempt radiology CAD and triage software from 510(k) review
What happenedFDA's final order, published September 17, denies a petition to exempt radiology CAD and triage software from 510(k) review for makers that already hold one clearance.
Why it mattersFor these product codes a prior clearance does not cover the next model — a question every buyer of AI-enabled devices should put to vendors.
For leadersAsk device vendors whether each shipped model version has its own clearance, not just the first.