Biomedical Engineering Reference
In-Depth Information
8. Becker, K.M. and Whyte, J.J. (2006) Clinical Evaluation of Medical Devices , Humana Press, Totowa, NJ.
9. Food and Drug Administration (FDA) (1976) Medical Device Amendments of the Food, Drug, and Cos-
metic Act, Definition 201(h).
10. Pisano, D.J. and Mantus, D.S. (2008) FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical
Devices, and Biologics , 2nd edn, Informa Healthcare, New York, NY.
11. Food and Drug Administration (FDA) (2011) 510(k) Database.
12. Food and Drug Administration (FDA) (2011) PMA Database.
13. Food and Drug Administration (1996) Final rule. Medical devices; current good manufacturing practice
(CGMP) final rule; quality system regulation. Federal Register , 61 (195), 52602 - 52662.
14. Food and Drug Administration (FDA) (2011) Product Classification Database.
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