Jurisdictional Update: Drug-Eluting Cardiovascular Stents

FDA has received several Requests for Designation (RFD) for cardiovascular stents coated with a drug component intended to maintain vessel patency by minimizing the occurrence of restenosis following stent implantation. Some of the drug components are active ingredients in drug products approved for other indications, while others are as yet unapproved.

Drug-eluting stents combine drug and device components, and are therefore combination products within the meaning of section 503(g) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 353(g)) (Act). Accordingly, review responsibility for these products is assigned based on the Agency’s determination of the product’s “primary mode of action” (Id.; 21 CFR § 3.4). FDA has determined based on the specific RFD’s submitted that the uncoated stent functions to physically maintain vessel lumen patency, while the drug component has played a secondary role in preventing restenosis, augmenting the safety and/or effectiveness of the uncoated stent. In these cases, FDA has concluded that the primary mode of action for the combination product is that of the device component, and has assigned the Center for Devices and Radiological Health (CDRH) primary responsibility for premarket review and regulation. In these cases, the clinical investigations of drug-eluting cardiovascular stents have been or will be conducted under an investigational device exemptions (IDE) application in accordance with 21 CFR Part 812, and CDRH expects to review marketing applications for the products under a premarket approval application (PMA) in accordance with 21 CFR Part 814. CDRH has conducted its reviews in consultation with the Center for Drug Evaluation and Research (CDER).

Furthermore, the assignment of primary review responsibility to CDRH is consistent with Sections VII.A.2 and VIII.A.5 of the current Intercenter Agreement between CDER and CDRH, which assigns CDRH review responsibility for devices incorporating a drug component with the combination product having the primary intended purpose of fulfilling a device function. Although the agency has determined that these products are subject to premarket review and approval solely under the medical device provisions of the Act, the agency has applied human drug Current Good Manufacturing Practices to the manufacture of the drug component of the combination product, and may apply other drug requirements to the products as appropriate. The CDRH review staff have discussed application of drug requirements in the context of specific applications.

Sponsors wishing to discuss regulation of a particular drug-eluting cardiovascular stent should contact the Interventional Cardiology Branch in the Division of Cardiovascular Devices, Office of Device Evaluation, CDRH by telephone at (301) 796-5570