eCFR Reference Browser

---

title: "21 CFR §821.60"

source: "https://www.ecfr.gov/current/title-21/section-821.60"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "821"

part_subject: "MEDICAL DEVICE TRACKING REQUIREMENTS"

subpart_code: "D"

subpart_subject: "Records and Inspections"

section_number: "821.60"

section_subject: "Retention of records."

cfr_reference: "21 CFR 821.60"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§821.60 - Retention of records.