The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has issued a final guidance on medical devices containing materials derived from animal sources.
Issued in mid-March, the guidance includes recommendations intended to help medical device manufacturers identify possible risks associated with tissues and other materials from animal sources when those tissues or materials are used in a medical device, as well as recommendations on minimizing such risks. Specifically, the guidance provides:
- Information on documenting the safe and consistent manufacture of medical devices containing animal tissue;
- Information that should be included in medical device premarket submissions;
- Recommendations on how to apply aspects of Quality System Regulations to medical devices containing animal tissue; and
- Some approaches for assessing manufacturing methods to eliminate viral contamination.
Guidances issued by the FDA are intended only to provide insight into the agency’s current thinking on a particular issue, and do not have the force of law. However, guidances can be helpful in developing a fuller understanding of how best to ensure compliance with FDA requirements.
Read the FDA’s final guidance on medical device materials derived from animal sources.
