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Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff.
Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff. Federal Register. Washington, DC: US Department of Health and Human Services. Baltimore, MD: Food and Drug Administration. July 9, 2015;80:39440-39441.
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October 21, 2015
Federal Register. Washington, DC: US Department of Health and Human Services. Baltimore, MD: Food and Drug Administration. July 9, 2015;80:39440-39441.
Heparin is a high-alert anticoagulant that has been associated with patient harm due to issues with administration and contamination. This draft guidance seeks to engage insights from the field to help improve labeling practices. The deadline for officially submitting comments was October 7, 2015.
