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