B Haggar
Abstract
This article describes the current regulatory activities of the Food and Drug Administration (FDA), in particular the FDA techniques for regulating medical-device approvals, medical-device reporting, and medical-device-company inspections. Also discussed are the FDA Modernization Act and the methods the FDA is using to implement the act.
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This article describes the current regulatory activities of the Food and Drug Administration (FDA), in particular the FDA techniques for regulating medical-device approvals, medical-device reporting, and medical-device-company inspections. Also discussed are the FDA Modernization Act and the methods the FDA is using to implement the act.
Key concepts: Food and drug administration, Medical device, Business, Modernization theory, Drug approval, Government regulation, Risk analysis (engineering), Drug