Use of Real-World Evidence for Regulatory Approval and Coverage of Medical Devices: A Landscape Assessment
Author:
Publisher
Elsevier BV
Subject
Public Health, Environmental and Occupational Health,Health Policy
Reference8 articles.
1. 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
2. Real-world evidence - what is it and what can it tell us?;Sherman;N Engl J Med,2016
3. Need for a national evaluation system for health technology;Shuren;JAMA,2016
4. Specific barriers to the conduct of randomised clinical trials on medical devices;Neugebauer;Trials,2017
5. Current considerations on real-world evidence use in FDA regulatory submissions;Whatley;Endovasc Today,2017
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