FDA to Begin Review Process for Final Stent Guidance

Now that it has incorporated industry comments into the final version of its coronary drug-eluting stent guidance, the FDA hopes to start the process of getting the changes approved by CDRH and the Center for Drug Evaluation and Research (CDER) by the end of this month. Without detailing how the final version of the guidance will differ from its draft, the FDA said there have been changes to the guidance, but they are not significant changes in policy.
Devices & Diagnostics Letter