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FDA Updates Guidance on Animal-Derived Products in Medical Devices

The FDA has updated its guidance on using animal-derived products in medical devices, replacing guidance issued back in 1998. The guidance describes the information manufacturers should document at the manufacturing facility and include in any pre-market submissions. Among other things, manufacturers should document the full history of the animal tissue along with their manufacturing methods to prove that there is no viral contamination in the final product. In addition to keeping complete records of the animal tissue used, the FDA recommends keeping track of test methods, quarantine procedures and methods of facility sterilisation to avoid cross-contamination.

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