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Medical Devices / Regulatory Affairs

FDA Finalizes Guidance on Devices Containing Materials From Animal Sources

March 18, 2019
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The FDA issued final guidance on medical devices containing materials derived from animal sources.

The guidance explains the agency’s current thinking on manufacturing controls for animal tissue components, control of tissue collection, device validation and considerations for prion diseases, which can cause fatal neurodegenerative diseases in humans and animals.

Despite animal-derived materials having an important role in medical devices, they “may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured,” the agency said.

The guidance includes recommendations for assessing the effectiveness of manufacturing methods in removing viral pathogens from final product.

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