FDA Finalizes Guidance for Labeling, Testing of Heparin Devices

The FDA issued guidance on labeling and safety testing for heparin-containing medical devices, finalizing the agency’s 2015 draft.

Heparin-containing combination products and medical devices should comply with the contaminant safety testing recommendations in the USP monograph on Heparin Sodium and follow CDER’s guidance on detection of oversulfated chondroitin sulfate (OSCS) contamination, the guidance says.

The FDA recommends that manufacturers receiving a heparin sodium drug substance or API represented as “USP” for use in a combination product should document that the substance has been tested according to the current USP drug substance monograph and that it was manufactured and tested in keeping with current heparin guidance.