The U.S. Food and Drug Administration has released a draft guidance to update its policies on the use of animal-derived material in medical device manufacturing so as to prevent the potential spread of infectious diseases such as mad cow disease.
The guidance describes the information you should document at the manufacturing facility and include in any premarket submissions. It is intended to help medical device manufacturers identify the possible risks related to tissues from animal sources when these tissues are used in medical devices.
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The guidance describes the information you should document at the manufacturing facility and include in any premarket submissions. It is intended to help medical device manufacturers identify the possible risks related to tissues from animal sources when these tissues are used in medical devices.
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