CDRH Tweaks Guidance on Medical Devices Containing Animal-Derived Materials

Regulatory NewsRegulatory News | 14 March 2019 |  By 

The US Food and Drug Administration (FDA) on Thursday finalized guidance from 2014, with new details on medical devices containing animal-derived materials.

The final guidance seeks to aid 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 added in the final version. The agency intends to update the final guidance as appropriate depending on whether “future revisions to the ISO 22442 series of standards result in significant changes to the recommendations in this document.”

New clarifications were applied throughout the entirety of the final guidance, including the considerations on manufacturing controls for animal tissue components and issues specific to transmissible spongiform encephalopathy (TSE). The guidance’s scope and the considerations on control of animal tissue collection and device sterilization validation were also revised from the draft.

Except for in vitro diagnostic devices, the draft guidance limited the scope of the information to “all medical devices that contain or are exposed to animal-derived materials.” The scope was extended to also include “materials generally recognized to be safe based on their method of manufacture.” It also now addresses the risks to patients and health care providers for devices that indirectly contact humans.

The finalized guidance provides new recommendations to help manufacturers comply with aspects of the quality system regulation for medical devices containing animal tissue and additional information on specific approaches to determine manufacturing methods to eliminate viral contamination. It supersedes the 1998 version of the guidance, which only addressed potential exposure to a specific TSE.



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