Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic)

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Owner: FDA (U.S Food and Drug Administration)

2019/04/23 15:00:00 | Long > 60 min | English | (GMT-4:00) Eastern Time (US and Canada)

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The role of animal-derived material in medical devices is well established. However, the use of animal materials introduces the risk of disease transmission from animals to humans.

The recommendations provided in this final guidance are intended to help medical-device manufacturers identify and minimize risks related to tissues from animal sources. 

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Irene Aihie

Email: DICE@fda.hhs.gov
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Irene Aihie is a Public Health Advisor in the FDA's Office of Communication and Education.

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