The FDA and Ensuring Safety and Effectiveness of Devices, Biologics, and Technology
Author:
Publisher
Ovid Technologies (Wolters Kluwer Health)
Subject
Orthopedics and Sports Medicine,Surgery
Reference16 articles.
1. Risk of recall among medical devices undergoing US Food and Drug Administration 510(k) clearance and premarket approval, 2008-2017;Dubin;JAMA Netw Open,2021
2. Reporting and notification of adverse events in Orthopaedics;Mihalko;J Am Acad Orthop Surg,2010
3. The FDA process for the evaluation and approval of orthopaedic devices;Kirkpatrick;J Am Acad Orthop Surg,2008
4. The methodology of clinical studies used by the FDA for approval of high-risk orthopaedic devices;Barker;J Bone Joint Surg Am,2017
5. Medical devices—Balancing regulation and innovation;Curfman;N Engl J Med,2012
Cited by 2 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. Risk of Recall for Total Joint Arthroplasty Devices Over 10 Years;The Journal of Arthroplasty;2023-08
2. Risk of Recall Associated With Modifications to High-risk Medical Devices Approved Through US Food and Drug Administration Supplements;JAMA Network Open;2023-04-12
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