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BMJ Surgery, Interventions, & Health Technologies
(Oct 2023)
Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative
Joseph S Ross,
Sanket S Dhruva,
Maryam Mooghali,
Vinay K Rathi,
Kushal T Kadakia
Affiliations
Joseph S Ross
Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
Sanket S Dhruva
Medicine, University of California San Francisco School of Medicine, San Francisco, California, USA
Maryam Mooghali
Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
Vinay K Rathi
Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear, Boston, Massachusetts, USA
Kushal T Kadakia
Harvard Medical School, Boston, Massachusetts, USA
DOI
https://doi.org/10.1136/bmjsit-2023-000186
Journal volume & issue
Vol. 5, no. 1
Abstract
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No abstracts available.
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