CFDA Issued Two Guidiance for Coronary Artery Drug Eluting Stents

On May 11, 2018 CFDA issued two guidiance for industry (CFDA Annoucement No. 21 in 2018). One is Preclinical Study Guidelines for Coronary Artery Drug Eluting Stents (DES). It guides industry on DES functional study and preclinical study. The other is Clinical Study Guidelines for Coronary Artery Drug Eluting Stents.