Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices): Guidance for Industry and Food and Drug Administration Staff

Issue Date: March 15, 2019
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Laboratory Tests
Status: Final

Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices): Guidance for Industry and Food and Drug Administration Staff

The Food and Drug Administration (FDA) is issuing this guidance to update the policy regarding the use of animal-derived material in medical device manufacturing. The role of animal-derived material in medical devices is well established. However, these materials may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured. The purpose of this guidance is to provide further clarification and updated information on the use of International Organization for Standardization (ISO) 22442-1 “Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management,” ISO 22442-2, “Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling,” and ISO 22442-3 “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” to support applications to FDA. This guidance also provides recommendations regarding methods for controlling the sourcing of animal tissues with regard to viral pathogens and evaluating the ability of manufacturing methods to remove such pathogens from the final product. This guidance replaces “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)” issued November 6, 1998 (“the 1998 guidance.”)

Download the Guidance Document