Medical device risk (re)classification: lessons from the FDA's 515 Program Initiative.

Competing Interests: Competing interests: MM reported receiving research support through Yale University from Arnold Ventures outside the submitted work. VKR reported having been employed by F-Prime Capital outside the submitted work. KTK reported being previously employed at the Cleveland Clinic London and the US Food and Drug Administration (FDA) and receiving consulting fees from the National Academy of Medicine, all unrelated to this manuscript. JSR reported receiving grants from the FDA, Johnson and Johnson, the Medical Devices Innovation Consortium, AHRQ, NIH, and Arnold Ventures and serving as an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled in Sep 2022. SSD reported receiving research funding from the Medical Device Innovation Consortium, Arnold Ventures and Department of Veterans Affairs.