What labeling changes are required for reprocessed single-use devices and when must the new labeling be used?
Any reprocessed single-use device (i.e., devices exempt from 510(k) requirements, subject to 510(k) requirements, or subject to a premarket report) introduced into interstate commerce after January 25, 2004 must “prominently and conspicuously” bear the statement: Reprocessed device for single use. Reprocessed by [name of manufacturer that reprocessed the device] . This provision will make it easier for patients and health care professionals to know when they are using a reprocessed device.
Related Questions
- When will FDA require validation data for reprocessed single-use devices that already require 510(k) clearance (i.e., devices that are not 510(k) exempt)?
- What labeling changes are required for reprocessed single-use devices and when must the new labeling be used?
- How will reprocessed single-use devices be regulated under the new law?
