Early experience with the FDA's Breakthrough Devices program

Affiliations

• ¹ Yale University School of Medicine, New Haven, CT, USA.
• ² San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.
• ³ Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, CA, USA.
• ⁴ Center for Outcomes Research and Evaluation (CORE), Yale-New Haven Hospital, New Haven, CT, USA.
• ⁵ Section of Health Policy and Administration, Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT, USA.
• ⁶ Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.
• ⁷ Department of Otolaryngology - Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston, MA, USA. vinay_rathi@meei.harvard.edu.