miércoles, 22 de enero de 2014

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Industry: Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) - Draft Guidance

The Food and Drug Administration (FDA) has issued a draft guidance to update the policy regarding the use of animal-derived material in medical device manufacturing.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.

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