Zdrowie i gospodarka · 9.07.2015
Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing." This draft guidance describes FDA's intent to address the safety concerns by clarifying new expectations for labeling with regard to the soon-to-be revised heparin United States Pharmacopeia (USP) monographs as well as outline safety testing recommendations. This draft guidance is not final nor is it in effect at this time.