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 SpotlightProprietary names usage for drug products, guidance Recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary names for drugs, including biological products, and other factors that, in association with the name, can contribute to medication errors are provided in a guidance published by the agency. Learn More » |
Topic SpotlightRegulatory site visit training program announced Interested biologics facilities are invited to participate in the FDA's Center for Biologics Evaluation and Research (CBER) Regulatory Site Visit Training Program. Learn More » |
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