CDRH Industry: Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) - Draft Guidance

The Food and Drug Administration (FDA) has issued a draft guidance to update the policy regarding the use of animal-derived material in medical device manufacturing.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 guidance describes the information you should document at the manufacturing facility and include in any premarket submissions.

Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) - Draft Guidance for Industry and Food and Drug Administration Staff