FDA previewed its pending drug eluting stent guidance document at the recent TCT back on October 15, 2008.
“The document will add a table outlining the engineering tests required for drug-eluting stents, beyond those required for bare-metal stents. These include coating integrity tests and particulate matter tests in three settings: baseline, simulated deployment and chronic use.”
The guidance also indicates that PMA submissions will require 18-month data on at least 50% of patients enrolled in clinical trials.
You can read more here.