Zdrowie i gospodarka · 15.03.2019
Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices); Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)." FDA is issuing this guidance to update the policy regarding the use of animal-derived material in medical device manufacturing. These animal-derived materials may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured. The guidance describes the information manufacturers should document at the manufacturing facility and include in any premarket submissions.