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 SpotlightImported food prior notice rules updated The FDA will require that prior notice of imported foods be submitted electronically via either the CBP Automated Broker Interface of the Automated Commercial System or the FDA Prior Notice System Interface. A final rule on imported foods was issued in the November 7, 2008, Federal Register along with a draft compliance policy guide (CPG) on which foods will be exempt from import notice requirements. Learn More » |
Topic SpotlightCertiorari petition filed in takings clause case A petition for writ of certiorari was filed in the U.S. Supreme Court on October 15, 2008, in Amerisource v. U.S. The petition was filed after a Federal Circuit U.S. Court of Appeal's decision in May of 2008 ruled that the Fifth Amendment's takings clause (the clause) does not apply when the government seizes an innocent third party's property for use in a criminal prosecution but never introduces the property into evidence, even when the property is rendered worthless over the course of the proceedings (¶39,029). Learn More » |
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