The 510(k) Third Party Review Program: Promise and Potential.

"Declarations Ethical ApprovalThis paper does not involve human and/or animal studies. Competing InterestsDr. Miller reports serving as a member of the CMS Medicare Evidence Development and Coverage Advisory Committee and receiving fees outside the related work from the Federal Trade Commission, the Health Resources and Services Administration, the California Association of Neurosurgeons, the Maryland Neurosurgical Society, the Digestive Health Physicians Association, and the Heritage Foundation. He also reports unrelated grant support from Arnold Ventures, the Mercatus Center, and the Ohio State University Drug Enforcement and Policy Center. Dr. Yagi reports unrelated grant support from the Ohio State University Drug Enforcement and Policy Center. DisclaimerThe views expressed are the authors’ own and do not necessarily represent the views of any of their employers or affiliations. Competing Interests Dr. Miller reports serving as a member of the CMS Medicare Evidence Development and Coverage Advisory Committee and receiving fees outside the related work from the Federal Trade Commission, the Health Resources and Services Administration, the California Association of Neurosurgeons, the Maryland Neurosurgical Society, the Digestive Health Physicians Association, and the Heritage Foundation. He also reports unrelated grant support from Arnold Ventures, the Mercatus Center, and the Ohio State University Drug Enforcement and Policy Center. Dr. Yagi reports unrelated grant support from the Ohio State University Drug Enforcement and Policy Center."

"Funding Dr. Miller and Dr. Yagi report funding from the Charles Koch Foundation, which had no role in this work."