Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices
Author:
Affiliation:
1. UCSF School of Medicine, San Francisco, California
2. Philip R. Lee Institute for Health Policy Studies, San Francisco, California
3. Editor, JAMA Internal Medicine
4. San Francisco Veterans Affairs Medical Center, San Francisco, California
Publisher
American Medical Association (AMA)
Subject
General Medicine
Link
https://jamanetwork.com/journals/jama/article-pdf/322/10/927/17879998/jama_redberg_2019_vp_190102.pdf
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4. JewettC. Hidden FDA reports detail harm caused by scores of medical devices. Kaiser Health News. March 7, 2019. https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/. Accessed June 5, 2019.
5. 80,000 deaths. 2 million injuries. It’s time for a reckoning on medical devices. New York Times. May 4, 2019. https://www.nytimes.com/2019/05/04/opinion/sunday/medical-devices.html. Accessed July 19, 2019.
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