2020
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
2017
US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016
Rathi VK, Gadkaree SK, Ross JS, Kozin ED, Sethi RK, Naunheim MR, Puram SV, Gray ST. US Food and Drug Administration Clearance of Moderate‐Risk Otolaryngologic Devices via the 510(k) Process, 1997‐2016. Otolaryngology 2017, 157: 608-617. PMID: 28786317, DOI: 10.1177/0194599817721689.Peer-Reviewed Original ResearchConceptsPremarket evidenceClinical evidenceClinical performance dataUS FoodAvailable FDA documentsFDA documentsEvidence of safetyDrug Administration clearanceOne-quarterNonclinical evidenceClinical practiceDrug AdministrationFDA clearanceOne-thirdTwo-thirdsClearanceFDATherapeutic devicesEvidenceSafetyOtolaryngologistsMajorityOtologic