Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019
Johnston JL, Dhruva SS, Ross JS, Rathi VK. Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019. JAMA Internal Medicine 2020, 180: 1701-1703. PMID: 33044513, PMCID: PMC7551221, DOI: 10.1001/jamainternmed.2020.3214.Peer-Reviewed Original Research