The Food and Drug Administration (FDA) has issued a draft guidance to update the policy regarding the use of animal-derived material in medical device manufacturing.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.
miércoles, 22 de enero de 2014
CDRH Industry: Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) - Draft Guidance
Publicado por salud equitativa en 8:32
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