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May 9, 2024 · For Immediate Release: May 09, 2024. Today, the U.S. Food and Drug Administration issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing...
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May 12, 2024 · Drug, any chemical substance that affects the functioning of living things and the organisms (such as bacteria, fungi, and viruses) that infect them. Pharmacology, the science of drugs, deals with all aspects of drugs in medicine, including their mechanism of action, physical and chemical.
May 9, 2024 · May 09, 2024 - 03:15 PM. The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devices needing maintenance or repair, advising that manufacturers include instructions necessary for proper servicing and provide examples of activities that constitute remanufacturing.
May 10, 2024 · The publication of the final guidance comes two years after Congress debated whether to define medical device remanufacturing in the FDA’s user fee bill. Months later, Congress extended the FDA’s authority to collect user fees through 2027 in legislation that made no mention of remanufacturing.
May 10, 2024 · The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Remanufacturing of Medical Devices.” This final guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.”
