Comments Sought on Device Tracking Collection

Federal Register notice: FDA is seeking comments on an information collection extension request for “Medical Devices; Device Tracking — 21 CFR Part 821.” FDA is given discretion in applying tracking provisions to medical devices meeting certain criteria and provides that tracking requirements for medical devices can be imposed only after it issues an order. Tracked device information is collected to help identify the current location of medical devices and patients possessing those devices, to the extent that patients permit the collection of identifying information. Manufacturers and FDA use the data to: (1) Expedite the recall of distributed medical devices that are dangerous or defective and (2) facilitate the timely notification of patients or licensed practitioners of the risks associated with the medical device. To view the notice, click here.