Zdrowie i gospodarka · 23.01.2014

Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices); Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices)." FDA is issuing this draft guidance to update the policy regarding the use of animal-derived material in medical device manufacturing.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 you should document at the manufacturing facility and include in any premarket submissions. This draft guidance is not final nor is it in effect at this time.