AdvaMed, AHA Say FDA Device Safety Action Plan Poses Safety Concerns

The Advanced Medical Technology Association (AdvaMed), the American Hospital Association and American College of Cardiology are concerned that aspects of FDA's Medical Device Safety Action Plan – including a voluntary 510(k) program for moderate-risk devices and a required software bill of materials (SBOM) – could create more medical device safety issues than it would solve, according to comments the groups recently submitted to FDA's docket. Medical device manufacturer Johnson & Johnson also commented on the plan, and while the company...