21 CFR 1010.3
Identification
21 CFR 1010.3 is the regulation titled “Identification” in 21 CFR Part 1010, Performance Standards for Electronic Products: General. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 801.18, in 1 letter
- Closed out
- 100% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 12025
- 02026
The regulation
Read the text of 21 CFR 1010.3 (eCFR, as of Sep 1, 2026)
(a) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use or in such other manner as may be prescribed in the applicable standard. Except for foreign equivalent abbreviations as authorized in paragraph (a)(1) of this section all such labels or tags shall be in the English language.
(1) The full name and address of the manufacturer of the product; abbreviations such as “Co.,” “Inc.,” or their foreign equivalents and the first and middle initials of individuals may be used. Where products are sold under a name other than that of the manufacturer of the product, the full name and address of the individual or company under whose name the product was sold may be set forth, provided such individual or company has previously suppled the Director, Center for Devices and Radiological Health with sufficient information to identify the manufacturer of the product.
(2) The place and month and year of manufacture:
(i) The place of manufacture may be expressed in code provided the manufacturer has previously supplied the Director, Center for Devices and Radiological Health with the key to such code.
(ii) The month and year of manufacture shall be provided clearly and legibly, without abbreviation, and with the year shown as a four-digit number as follows in this paragraph. Alternatively, a manufacturer may utilize a manufacturing symbol and date format that conforms with an applicable FDA recognized consensus standard.
(b) In the case of products for which it is not feasible to affix identification labeling in accordance with paragraph (a) of this section, upon application by the manufacturer, the Director, Center for Devices and Radiological Health may approve an alternate means by which such identification may be provided.
(c) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall provide to the Director, Center for Devices and Radiological Health a list identifying each brand name which is applied to the product together with the full name and address of the individual or company for whom each product so branded is manufactured.
[40 FR 32257, July 31, 1975, as amended at 42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988; 88 FR 3653, Jan. 20, 2023]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1010.3.
- 21 CFR 801.18Format of dates provided on a medical device label1 letter cites both
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
- 21 CFR 801.3Definitions1 letter cites both
- 21 CFR 801.40Form of a unique device identifier1 letter cites both
- 21 CFR 803.12How do I submit initial and supplemental or followup reports?1 letter cites both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 803.18What are the requirements for establishing and maintaining MDR files or records that apply to me?1 letter cites both
- 21 CFR 803.3How does FDA define the terms used in this part?1 letter cites both
Latest letters citing it
The letter citing 21 CFR 1010.3 that FDA posted most recently.
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