FDA News reports that manufacturers of coronary drug-eluting stents should provide the results of biocompatibility tests of the bare-stent platform. The edict comes from a final guidance by the European Medicines Agency’s (EMEA) Committee on Human Medicinal Products.

According to the committee, biocompatibility test results for all relevant materials, including carrier and stent material, must be submitted to the national competent authorities and the EMEA, and firms should document the extent to which testing conforms to ISO 10993.

The guidance becomes effective Dec. 1. It covers the clinical and nonclinical aspects of the assessment of ancillary medicinal substances contained in drug-eluting stents. It describes a range of drug-device situations and the data required to adequately evaluate the drugs contained in the stent. “Guideline on the Clinical and Non Clinical Evaluation During the Consultation Procedure on Medicinal Substances Contained in Drug-Eluting (Medicinal Substance-Eluting) Coronary Stents” is available at www.emea.europa.eu/pdfs/human/ewp/11054007enfin.pdf.