21 CFR § 830.330 - Times for submission of unique device identification information.

---
identifier: "/us/cfr/t21/s830.330"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 830.330 - Times for submission of unique device identification information."
title_number: 21
title_name: "Food and Drugs"
section_number: "830.330"
section_name: "Times for submission of unique device identification information."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "830"
part_name: "UNIQUE DEVICE IDENTIFICATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371."
regulatory_source: "78 FR 58823, Sept. 24, 2013, unless otherwise noted."
cfr_part: "830"
---


# 830.330 Times for submission of unique device identification information.

(a) The labeler shall submit to FDA the information required by § 830.310 no later than the date the label of the device must bear a unique device identifier under § 801.20 of this chapter.

(b) The labeler of a device shall submit to FDA an update to the information required by § 830.310 whenever the information changes. The updated information must be submitted no later than the date a device is first labeled with the changed information. If the information does not appear on the label of a device, the updated information must be submitted within 10 business days of the change.