Medical Devices; Device Tracking

This ICR collects information from device manufactures and distributors who are subject to the requirements for device tracking, tracking systems, and distributor reporting. Manufacturers must track a class II or class III device if its failure would be reasonable likely to have serious adverse health consequences, or it is intended to be implanted in the human body for more than one year, or it is life-sustaining or life-supporting and used outside a device user facility, or when FDA determines that tracking would be appropriate in order to protect the general public in the event of a device recall.

The latest form for Medical Devices; Device Tracking expires 2021-03-31 and can be found here.

Discontinuation of business

Federal Enterprise Architecture: Health - Consumer Health and Safety