On March 15, 2019, FDA issued a final guidance entitled “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Guidance for Industry and Food and Drug Administration Staff” to assist stakeholders identify and mitigate the potential risks related to animal-sourced medical device components and/or raw materials.
The guidance builds on the recommendations expressed in a 2014 draft document and addresses a broader range of viral pathogens and transmissible spongiform encephalopathies (TSEs) than the previous 1998 version.
The guidance aligns with the ISO 22442 series of standards “Medical Devices utilizing animal tissues and their derivatives ” and addresses specific aspects of the Quality System Regulation (QSR), i.e. how tissue collection, manufacturing, and sterilization controls should be applied to ensure the (documented) safe and consistent manufacture of Medical Devices containing animal tissue.
Last, but not least, FDA provides a list with the information to include in premarket submissions for products that fall within the scope of this guidance: medical device components (e.g., pericardium, viscera, bone, hyaluronic acid, collagen) and/or manufacturing reagents (e.g., tissue culture media, enzymes).
