Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database-Reference-Cited by-同舟云学术

Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database

Published:2020-01-01 Issue:1 Volume:180 Page:147
ISSN:2168-6106
Container-title:JAMA Internal Medicine
language:en
Short-container-title:JAMA Intern Med

Author:

Meier Lily¹,Wang Elizabeth Y.²,Tomes Madris³,Redberg Rita F.⁴⁵

Affiliation:

1. Bates College, Lewiston, Maine

2. School of Medicine, University of California, San Francisco

3. Device Events, York, Pennsylvania

4. Department of Medicine, University of California, San Francisco

5. Editor, JAMA Internal Medicine

Publisher

American Medical Association (AMA)

Subject

Internal Medicine

Link

https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/2752362/jamainternal_meier_2019_ld_190043.pdf

Reference6 articles.

1. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.;Dhruva;JAMA,2009

2. FDA flags inconsistent hospital reporting of medical device problems: hazy reporting rules beget confusion.;Barlas;P T,2017

3. The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies.;Carroll;J Am Coll Cardiol,2013

4. US Food and Drug Administration. Mandatory reporting requirements: manufacturers, importers and device user facilities. https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/reportingadverseevents/default.htm. Updated May 2, 2019. Accessed August 29, 2019.

5. Device Events. https://www.deviceevents.com/. Accessed April 20, 2019.

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