Following up on the recent regulatory storm regarding drug eluting coronary stents, the FDA has issued guidance notes for the industry for the development, testing, clinical studies, and manufacture of the devices.
From the FDA:
This draft guidance, announced in today’s Federal Register discusses the development pathway for new drug-eluting stents and provides recommendations on information necessary for a complete marketing submission. It also provides guidance on assessing the toxicity of the drug used to coat the stent, both on its own and as part of the complete product. Because these stents combine device and drug technology, this guidance contains expertise and input from two agency centers—the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research.
Also included are draft recommendations for engineering tests, biocompatibility tests, and animal studies to assess the device’s overall safety.