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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Topic SpotlightCountries may seek exemptions from BSE restrictions Upon application and review, the FDA may designate a country as not subject to bovine spongiform encephalopathy (BSE, “mad cow disease”) restrictions applicable to human food and cosmetics manufactured from, processed with, or that otherwise contain: specified risk materials, the small intestine of cattle (unless the distal ileum is removed), material from nonambulatory disabled cattle, or mechanically separated beef. Amending the definition of “ prohibited cattle materials” in two previous interim final rules, the FDA concurred with previously submitted comments that it was not necessary for all BSE-related restrictions to apply to human food and cosmetics regardless of a country's BSE status. Learn More » |
Topic SpotlightClinical trial databank certification guidance issued A draft guidance for industry, clinical researchers and FDA staff about clinical trial information and documents submitted to the FDA that typically need not be certified under Section 402(j) of the Public Health Service Act has been issued by the FDA for comment. The draft guidance is called “ Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of the Public Health Service Act (PHS Act), Added by Title VIII of the Food and Drug Administration Amendments Act of 2007.” Learn More » |
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