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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2019]
[CITE: 21CFR830.330]
See Related Information on Times for submission of unique device identification information. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 830 -- UNIQUE DEVICE IDENTIFICATION

Subpart E--Global Unique Device Identification Database

Sec. 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.

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