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 ResearchCharacterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study
Mooghali M, Ross J, Kadakia K, Dhruva S. Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study. Medical Devices Evidence And Research 2023, 16: 111-122. PMID: 37229515, PMCID: PMC10204764, DOI: 10.2147/mder.s412802.Peer-Reviewed Original ResearchCross-sectional studyClass I medical deviceClass IHigh-risk medical devicesSerious adverse eventsSafety concernsAdverse eventsMedian numberUS FoodRecalled deviceTherapeutic useDevice recallsHigh-risk devicesDevice useSerious safety concernsMedical device recallsMultiple recallsLife-sustaining devicesDevice assessment