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# Device Tracking Information Collection
- URL: https://www.fdaweb.com/device-tracking-information-collection/
- Published: 2023-12-05T12:00:00.000Z
- Updated: 2026-09-14T14:17:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155924

*Federal Register* notice: FDA has submitted to OMB an information collection extension entitled “Medical Devices; Device Tracking — 21 CFR Part 821.” The collection supports the agency’s 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. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-05/pdf/2023-26653.pdf?ref=fdaweb.com).