Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019-Reference-Cited by-同舟云学术

Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019

Published:2020-12-01 Issue:12 Volume:180 Page:1701
ISSN:2168-6106
Container-title:JAMA Internal Medicine
language:en
Short-container-title:JAMA Intern Med

Author:

Johnston James L.¹,Dhruva Sanket S.²³,Ross Joseph S.⁴⁵⁶,Rathi Vinay K.⁷⁸

Affiliation:

1. Yale School of Medicine, New Haven, Connecticut

2. San Francisco Veterans Affairs Medical Center, San Francisco, California

3. Department of Medicine, University of California School of Medicine, San Francisco

4. Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, Connecticut

5. Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut

6. Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut

7. Department of Otolaryngology–Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston

8. Harvard Business School, Boston, Massachusetts

Publisher

American Medical Association (AMA)

Subject

Internal Medicine

Link

https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/2771667/jamainternal_johnston_2020_ld_200045_1606936104.12476.pdf

Reference6 articles.

1. Cerebral embolic protection devices in transcatheter aortic valve replacement—effective in stroke prevention?;Khera;JAMA Intern Med,2020

2. Modernizing the FDA’s 510(k) pathway.;Rathi;N Engl J Med,2019

3. Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011.;Rathi;JAMA,2015

4. Mulero A. FDA’s De Novo program gains momentum. Regulatory Focus. April 4, 2019. Accessed May 29, 2020. https://www.raps.org/news-and-articles/news-articles/2019/4/fdas-de-novo-program-gains-momentum

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