Explanations, regulations, court decisions, proposals, final rules, guidance, and other news regarding the classification, general controls, special controls, premarket approval, and recall of medical devices. Specific coverage areas include enforcement issues, adulteration, labeling, premarket notification, good manufacturing practices, preformance standards, preemption, and investigational use exemptions. Select from the list of Medical Devices products below:
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Your resource for comprehensive coverage of law relating to medical devices.
News Headlines |
Topic SpotlightIRB continuing review of subjects' welfare; draft guidance Institutional review boards (IRBs) should review their responsibilities regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations, according to a draft guidance published by the FDA. Learn More » |
Topic SpotlightGAO: Drug price increases due to lack of competition The Government Accountability Office (GAO) attributed the sudden and rapidly growing costs of brand-name prescription drugs in part to a lack of therapeutically equivalent brand-name and generic drugs. Learn More » |
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