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21 CFR 801.20: Label to bear a unique device identifier

Requires every medical device label and device package to bear a unique device identifier meeting UDI labeling and Part 830 requirements, unless a specified exception applies or FDA grants an exception or alternative.

Part 801, Labeling · Subpart B, Labeling Requirements for Unique Device Identification

How FDA words it

The opening lines investigators use most when they cite 801.20, from the 483s we hold.

The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.Most used

Cited over time

483s citing 801.20, by year

Most citations in 2025. Bars are relative to the busiest year. *2026 to date.

Years shown: 2017 to 2026. The busiest year was 2025.

Recent 483s citing 801.20

See all 483s citing 801.20

The regulation text

§ 801.20 Label to bear a unique device identifier.

(a)In general. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter.

(2)Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter.

(b)Exceptions. Exceptions to the general rule of paragraph (a) of this section are provided by §§ 801.30, 801.45, and 801.128(f)(2), and § 801.55 provides a means to request an exception or alternative not provided by those provisions.

[78 FR 58818, Sept. 24, 2013]

Questions

What does 21 CFR 801.20 require?

Requires every medical device label and device package to bear a unique device identifier meeting UDI labeling and Part 830 requirements, unless a specified exception applies or FDA grants an exception or alternative.

How do FDA investigators word a 801.20 observation?

The most common opening is: “The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.”

Which sections are cited alongside 801.20?

In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.30 (Design controls), 820.50 (Purchasing controls).