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:
An invaluable resource providing everything you need to know about Food and Drug Regulations.
Your resource for comprehensive coverage of law relating to medical devices.
News Headlines |
Topic SpotlightCardiovascular risk in antidiabetic therapies; guidance The FDA released a guidance making recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. Learn More » |
Topic SpotlightOrphan product development grants available The FDA's Office of Orphan Product Development (OPD) will give grants totaling over $14 million in fiscal year (FY) 2010 for orphan product studies. The office anticipates similar funding for FY 2011. Learn More » |
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