Modernizing the FDA's 510(k) Pathway

Affiliations

¹ From the Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, and Harvard Business School - both in Boston (V.K.R.); and the Center for Outcomes Research and Evaluation (CORE), Yale New Haven Hospital, the Department of Health Policy and Administration, Yale School of Public Health, and the Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine - all in New Haven, CT (J.S.R.).

Vinay K Rathi et al. N Engl J Med. 2019.

. 2019 Nov 14;381(20):1891-1893.

doi: 10.1056/NEJMp1908654. Epub 2019 Oct 23.

¹ From the Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, and Harvard Business School - both in Boston (V.K.R.); and the Center for Outcomes Research and Evaluation (CORE), Yale New Haven Hospital, the Department of Health Policy and Administration, Yale School of Public Health, and the Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine - all in New Haven, CT (J.S.R.).

No abstract available

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