2023
Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022
Mooghali M, Ross J, Kadakia K, Dhruva S. Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022. JAMA Internal Medicine 2023, 183: 735-737. PMID: 37184854, PMCID: PMC10186206, DOI: 10.1001/jamainternmed.2023.0727.Peer-Reviewed Original ResearchUse of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls
Kadakia K, Dhruva S, Caraballo C, Ross J, Krumholz H. Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls. JAMA 2023, 329: 136-143. PMID: 36625810, PMCID: PMC9857464, DOI: 10.1001/jama.2022.23279.Peer-Reviewed Original Research
2017
Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979–2015
Gopal AD, Rathi VK, Teng CC, Del Priore L, Ross JS. Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979–2015. Ophthalmology 2017, 124: 1237-1246. PMID: 28501378, DOI: 10.1016/j.ophtha.2017.03.040.Peer-Reviewed Original Research
2015
How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
Samuel AM, Rathi VK, Grauer JN, Ross JS. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval? Clinical Orthopaedics And Related Research® 2015, 474: 1053-1068. PMID: 26584802, PMCID: PMC4773325, DOI: 10.1007/s11999-015-4634-x.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesDatabases, FactualDevice ApprovalEquipment DesignHumansMedical Device RecallsOrthopedic EquipmentOrthopedic ProceduresPatient SafetyProduct Surveillance, PostmarketingRetrospective StudiesRisk FactorsSafety-Based Medical Device WithdrawalsTime FactorsUnited StatesUnited States Food and Drug Administration