The US Food and Drug Administration (FDA) on has finalised its guidance, drafted in 2014, for medical devices containing animal-derived materials.
The Agency states that the final guidance seeks to help industry address the risks of human pathogens that could contaminate animal material, and thus be present in a medical device that contains contaminated material derived from animal sources.
“The role of animal-derived material in medical devices is well established,” FDA’s Center for Devices and Radiological Health (CDRH) said on Thursday. “However, the use of animal materials introduces the risk of disease transmission from animals to humans.”
The 13-page final document builds on clarifications provided in the 2014 draft, at least in part due to concerns industry raised in submissions during the draft’s comment period. A concern with the drafted guidance led critics to urge CDRH to reference the ISO 22442:2007 series of standards, which addresses animal-derived tissue use.
“Used in concert with the ISO 22442 series of standards, this guidance is intended to help you identify the possible risks related to medical device components and/or manufacturing reagents that are sourced from animal tissues,” CDRH states in the final version.