If you're reprocessing single-use devices (SUDs), take note. The FDA has revised the guidelines covering procedures and timeframes for reviewing the validation data submitted to the FDA for certain SUDs. The "Validation Data in Premarket Notification Submissions (5109(k)s) for Reprocessed Single-Use Medical Devices," which supersedes last year's document of the same name, is available at writeOutLink("www.fda.gov/cdrh/ode/guidance/1216.html",1). The 23-page guidance is a bit much to wade through, so here's what you need to know.