Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices), guidance for FDA reviewers and industry; availability--FDA. Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry." This guidance is intended to provide recommendations for information that is to be included in premarket submissions--investigational device exemption (IDE), premarket approval application (PMA), and 510(k) submissions for medical devices that either contain or are exposed to animal-derived materials during manufacturing.
D000820:Animal Diseases / Q000517:prevention & control* / Q000635:transmission; D000818:Animals; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration