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.

Mooghali, Maryam; Ross, Joseph S; Kadakia, Kushal T; Dhruva, Sanket S

Mooghali, Maryam; Ross, Joseph S; Kadakia, Kushal T; Dhruva, Sanket S.

Afiliação

Mooghali M; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Ross JS; Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT, USA.
Kadakia KT; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Dhruva SS; Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT, USA.

Med Devices (Auckl) ; 16: 111-122, 2023.

Article em En | MEDLINE | ID: mdl-37229515

Palavras-chave

Food and Drug Administration; device safety; medical devices recalls

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Etiology_studies / Observational_studies / Prevalence_studies / Risk_factors_studies Idioma: En Revista: Med Devices (Auckl) Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos

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