The US Food and Drug Administration (FDA) has issued final guidance on medical devices containing materials derived from animal sources on March 15, 2019.The guidance is intended to help medical device companies establish and document procedures that mitigate risk of infectious disease exposure through contact with devices containing animal-derived materials.

In the final guidance, the recommendations for tissue collection, manufacturing, and sterilization controls align with procedures specified in the ISO 22442 series of standards, “Medical devices utilizing animal tissues and their derivatives.” The guidance recommends conducting viral inactivation validation studies to ISO 22442 Part 3 and references a list of consensus standards that specify other relevant sterilization methods.

Manufacturers will also find recommendations on preparing pre-market submissions that align with ISO 22442 as well as on applying relevant sections of the Quality System Regulation (QSR) to devices containing animal-derived substances. The guidance does not apply to in vitro diagnostic (IVD) devices or to devices containing only materials derived from human cells or tissues (commonly known as HCT/Ps).