Guidance on regulating medical devices manufactured from or incorporating viable or non-viable animal tissue or their derivative(s): References

CAN/CSA-ISO 14971:2007, Medical Devices - Application of Risk Management to Medical Devices. Second edition 2007-03-01.

CDC. 2015. Variant Creutzfeldt-Jakob disease (vCJD): Relationship with BSE (Mad Cow Disease). Center for Disease Control and Prevention. Atlanta, GA, USA.

CFIA. 2014. Evaluation of the bovine spongiform encephalopathy (BSE) management program. Canadian Food Inspection Agency. Government of Canada.

CFIA. 2005. Bovine spongiform encephalopathy import policy for bovine animals and their products and by-products. Document# TAHD-DSAT-IE-2005-9-7. Updated Feb. 10, 2017.

Health of Animals Regulations (C.R.C., c. 296), Health of Animals Act Part XIV Sections 162-170.

ICH. 1999. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH)/Therapeutic Products Programme Guidance. Q5A(R1), Step 4 version. Sept. 23, 1999.

ISO 22442-1:2015, Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management. Second edition, Nov. 1, 2015.

ISO 22442-2:2015, Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling. Second edition, Nov. 1, 2015.

ISO 22442-3:2007, Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents. First edition, Dec. 15, 2007.

ISO/TR 22442-4:2010, Medical devices utilizing animal tissues and their derivatives – Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes. First edition, Dec 1, 2010.

Lukan et al. 2013. TSE diagnostics: Recent advances in immunoassaying prions. Clinical and Developmental Immunology. 2013:8.

OIE. 2022. Bovine spongiform encephalopathy: list of bovine spongiform encephalopathy risk status of member countries. World Organisation for Animal Health.

US FDA. 2019. Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices): Guidance for industry and Food and Drug Administration staff. U.S. Department of Health and Human Services. Food and Drug Administration Center for Devices and Radiological Health.

WHO. 2010. WHO tables on tissue infectivity distribution in transmissible spongiform encephalopathies. World Health Organization. Geneva, pp. 21.

WHO. 2006. WHO guidelines on tissue infectivity distribution in transmissible spongiform encephalopathies. World Health Organization. France, pp. 59.