Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices-Reference-Cited by-同舟云学术

Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices

Published:2019-09-10 Issue:10 Volume:322 Page:927
ISSN:0098-7484
Container-title:JAMA
language:en
Short-container-title:JAMA

Author:

Redberg Rita F.¹²³,Dhruva Sanket S.¹⁴

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

Reference10 articles.

1. Need for a National Evaluation System for Health Technology.;Shuren;JAMA,2016

2. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema.;Fishman;N Engl J Med,2003

3. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.;Reynolds;JAMA Intern Med,2014

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.

Cited by 22 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. The science and practice of imaging-based screening: What the radiologist needs to know;Clinical Imaging;2024-10

2. Regulatory requirements for joint replacements;Joint Replacement in the Human Body;2024

3. eStar: A New Way to Submit Your 510(K) Notification;2023 4th International Conference on Computation, Automation and Knowledge Management (ICCAKM);2023-12-12

4. Data Requirement for Animal-Derived Wound Care Devices: Limitations of the 510(k) Regulatory Pathway;Journal of the American College of Surgeons;2023-10-05

5. FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks;The Lancet Digital Health;2023-09