Draft Murray Bill Requires Cleaning Instructions For Some Reusable Devices, Clarifies 510(k) Mods' Premarket Rules

The Senate health committee's top Democrat is set to introduce legislation that would require FDA publish a list of reusable devices that would require specific labeling, and issue guidance outlining when modifications of devices cleared under the 510(k) pathway require premarket notification. The draft language, provided to Inside Health Policy by sources off Capitol Hill, is expected to be included in the Feb. 9 markup of the Senate's counterpart package to the House-passed 21st Century Cures. The legislation, introduced on...