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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News Headlines |
Topic SpotlightOpioid REMS comment period reopened The FDA reopened until October 19, 2010, the comment period of a public meeting held on May 27 and 28, 2009, to solicit input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. Learn More » |
Topic SpotlightPharmacologic class descriptions guidance issued A guidance to help applicants and the review staff in the FDA's Center for Drug Evaluation and Research determine when a drug belongs to an established pharmacologic class, as well as how to select the appropriate word, phrase, or term that describes the pharmacologic class for inclusion in approved prescription drug labeling was issued by the FDA. Learn More » |
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