FDA’s Device Labeling Proposed Rule Misses The Mark, Industry Says-graysheet: FDA issued its proposed rule in April on “Use of Certain Symbols in Labeling,” which would allow medical device and biological product makers to include symbols to convey information to users without the previous requirement of including explanatory text next to the symbol. (See "FDA Proposes Rule On Symbols In Device Labeling" — "The Gray Sheet," Apr. 22, 2013.) But to use stand-alone symbols, FDA says firms must explain the symbols in a comprehensive glossary that accompanies the device, a requirement that many in industry say is duplicative and unnecessary.
