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# Info Collection on Medical Device Tracking
- URL: https://www.fdaweb.com/info-collection-on-medical-device-tracking/
- Published: 2021-02-12T12:00:00.000Z
- Updated: 2026-09-14T16:46:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148658

*Federal Register* notice: FDA has submitted to OMB an information collection extension entitled “Medical Devices; Device Tracking — 21 CFR Part 821” (OMB Control Number 0910-0442). FDA regulations provide it the authority to require by order that a manufacturer adopt a method for tracking a Class 2 or 3 medical device, if the device meets one of the three following criteria: (**1**) the failure of the device would be reasonably likely to have serious adverse health consequences, (**2**) the device is intended to be implanted in the human body for more than one year, or (**3**) the device is life-sustaining or life-supporting and is used outside a device user facility. Tracked device information is collected to facilitate identifying the current location of medical devices and patients possessing those devices. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-03017.pdf?ref=fdaweb.com).