HHS issued its semiannual regulatory agenda Jan. 7, updating the department’s rulemaking activities it plans to undertake in the coming year. The list is an update from the agenda issued in July 2013. Among the completed items on the list is the unique device identifier final rule, published in September 2013. (See [A#29130923003].) Device-related items that are expected be issued as proposed rules include, “Format and Content of Reports Intended to Demonstrate Substantial Equivalence,” “Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System,” and “Mammography Quality Standards Act; Regulatory Amendments.” Upcoming final rules include, “Laser Products; Proposed Amendment to Performance Standard” and “Use of Certain Symbols in Labeling.” Items listed as “Long-Term Actions” include, “Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices.”
FDA issued a proposed order Jan. 7 to reclassify nonroller-type cardiopulmonary bypass blood pump devices when used for cardiopulmonary and circulatory bypass, a class III pre-amendments device type,...
