FDA Unveils New Guidelines for Biocombatibility Testing of Medical Devices

The FDA has released draft guidance to standardize biocompatibility testing for medical devices, addressing inconsistencies found in premarket submissions. The new document aims to resolve lab-to-lab variability in analytical chemistry by providing clear recommendations for chemical analysis. This guidance focuses on extractables studies, which identify and quantify substances released from a device under laboratory conditions.

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To ensure reliable and consistent data, the FDA recommends specific methodologies, including performing extractions in triplicate. The agency invites feedback on the draft until November 18, encouraging industry participation to refine the guidelines.

Check out the new guidelines yourself here: