21 CFR 821.60
§ 821.60 Retention of records.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 821.60, § 821.60 Retention of records, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88917
- Permanent ID
ys:prov:88917@1- SHA-256
8d2de0c7c1e3bf0bb44c9d0463dd1117e4709a29bc44980614fc247912241b56
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
Persons required to maintain records under this part shall maintain such records for the useful life of each tracked device they manufacture or distribute. The useful life of a device is the time a device is in use or in distribution for use. For example, a record may be retired if the person maintaining the record becomes aware of the fact that the device is no longer in use, has been explanted, returned to the manufacturer, or the patient has died.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.