FDA Proposes to Allow Symbols on Medical Device Labels

The Food and Drug Administration is proposing to allow symbols on labeling for medical devices and biological products, as long as the symbol has been established as part of a standard developed by a nationally or internationally-recognized standards development organization. The standardized symbol will have to be part of a standard recognized by FDA for use on medical devices, and it would have to be explained in a symbols glossary that accompanies the device, the agency said. FDA is also proposing to allow the statement “Rx only” on the labeling of prescription devices. Comments on information collection aspects of the proposed rule are due by May 20, and comments on all other parts of the proposal are due by June 18.