October 2001 Bulletin

FDA posts special controls for cement

The Food and Drug Administration has posted "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement 510(k)s; Final Guidance for Industry." In 1999, the FDA reclassified PMMA bone cement from class III to class II. This document is the special controls guidance for PMMA bone cement. The topics in the new document include the scope of use, risks to health, controls, intended use/indications for use, need for clinical trials for new intended use and changes in chemical formula and labeling. The document it at: http://www.fda.gov/cdrh/ode/guidance/668.html


Home Previous Page