ABSTRACT

The Web page reproduced here is maintained by the FDA's Center for Devices and Radiological Health. It explains what types of guidances the CDRH's Office of Device Evaluation (ODE) is responsible for developing and then lists, organized by category, all the guidances or "Blue Book Memos" produced by the ODE. Each of the guidance documents listed is a link to the full-text version of that guidance document. To make sure you have access to the most recently available guidances, you should visit the Web page at https://www.fda.gov1cdrh/blbkmem.html.