Today, the FDA issued a draft guidance document titled “Medical Devices Containing Materials Derived from Animal Sources” to help you identify the possible risks when animal sources are used in medical devices.
The Food and Drug Administration (FDA) is updating its policy regarding the use of animal-derived materials in medical device manufacturing to reduce the risk of transmitting infectious diseases. The guidance broadens the discussion of transmissible spongiform encephalopathies (TSEs) beyond the 1998 discussion of reducing exposure to bovine spongiform encephalopathy (BSE). This draft guidance is applicable to all manufacturers that produce medical devices that contain or are exposed to animal-derived materials (e.g., bovine, ovine, porcine, avian materials) with the exception of in vitro diagnostic devices.
The medical device industry will have an opportunity to submit comments and suggestions regarding the draft guidance within 90 days of publication in the Federal Register of the notice. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm381379.htm