The Role of the FDA and Regulatory Approval of New Devices for Diabetes Care
Author:
Publisher
Springer Science and Business Media LLC
Subject
Endocrinology, Diabetes and Metabolism,Internal Medicine
Link
http://link.springer.com/article/10.1007/s11892-017-0871-6/fulltext.html
Reference76 articles.
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3. Kaplan AV, Williams DO. Medical device regulatory landscape: the imperative of finding balance. Circ Cardiovasc Interv. 2012;5:2–5. doi: 10.1161/CIRCINTERVENTIONS.112.968560 .
4. Pub L No. 94-295 (1976).
5. • Sastry A. Overview of the US FDA medical device approval process. Curr Cardiol Rep. 2014;16:494. doi: 10.1007/s11886-014-0494-3 . This review article provides an overview of the FDA’s structure and the regulatory landscape, as well as roles clinicians play in the review, approval, and surveillance of medical devices.
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