FDA Issues Final Guidance on Medical Devices Containing Materials Derived from Animal Sources

Today, the U.S. Food and Drug Administration (FDA) issued the final guidance, “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).” 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 manufacturers identify the possible risks related to tissues from animal sources when these tissues are used in medical devices. This guidance also provides recommendations on how to minimize these risks.

Facts About the Guidance

This final guidance supersedes the 1998 version of the guidance.
The final guidance includes recommendations related to viral pathogens and all transmissible spongiform encephalopathies (TSEs).
The final guidance provides information that FDA believes is important to document the safe and consistent manufacture of medical devices containing animal tissue, as well as information that should be included in a premarket submission for products within the scope of this guidance.
The recommendations in the final guidance are generally consistent with the International Organization for Standardization (ISO) 22442 series of standards; the guidance provides clarification and updated information on use of these standards to support regulatory submissions to the FDA.
The final guidance includes recommendations regarding how the Quality System (QS) Regulation should be applied to control and document the safe and consistent manufacture of medical devices containing animal tissue, along with specific approaches for determining the ability of manufacturing methods to eliminate viral contamination in the final product.