Medical device risk (re)classification: lessons from the FDA's 515 Program Initiative.

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

Afiliação

Mooghali M; Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
Rathi VK; Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear, Boston, Massachusetts, USA.
Kadakia KT; Harvard Medical School, Boston, Massachusetts, USA.
Ross JS; Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
Dhruva SS; Medicine, University of California San Francisco School of Medicine, San Francisco, California, USA.

BMJ Surg Interv Health Technol ; 5(1): e000186, 2023.

Article em En | MEDLINE | ID: mdl-38033980