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GUIDANCE DOCUMENT

Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing Guidance for Industry and Food and Drug Administration Staff September 2018

Final

Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing

Docket Number:
FDA-2015-D-2167
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The United States Pharmacopeia (USP) drug substance monograph for Heparin Sodium, and drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection, recently have undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a major contributing factor in these errors. This guidance document addresses these safety concerns by clarifying new expectations for labeling with regard to the revised heparin USP monographs, as well as outlining safety testing recommendations.


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All written comments should be identified with this document's docket number: FDA-2015-D-2167.