The U.S. FDA notice regarding device risk classification proposes to eliminate premarket notification requirements for several device types, a welcome development for industry. However, Amanda Johnston, senior attorney at Gardner Law PLLC, of Stillwater, Minn., told BioWorld that there is a question regarding the provenance of the document, as it fails to identify any FDA staff member. In addition, the notice omits several device types that are solid candidates for down-classification.