21 CFR 801.1
Medical devices; name and place of business of manufacturer, packer or distributor
21 CFR 801.1 is the regulation titled “Medical devices; name and place of business of manufacturer, packer or distributor” in 21 CFR Part 801, Labeling. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 803.17, 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
- 12024
- 02025
- 02026
The regulation
Read the text of 21 CFR 801.1 (eCFR, as of Sep 1, 2026)
(a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.
(b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for “Company,” “Incorporated,” etc., may be used and “The” may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.
(c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, “Manufactured for ___”, “Distributed by _____”, or any other wording that expresses the facts.
(d) The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice).
(e) If a person manufactures, packs, or distributes a device at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such device was manufactured or packed or is to be distributed, unless such statement would be misleading.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 801.1.
- 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 803.20How do I complete and submit an individual adverse event report?1 letter cites both
- 21 CFR 803.3How does FDA define the terms used in this part?1 letter cites both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1 letter cites both
- 21 CFR 807.20Who must register and submit a device list?1 letter cites both
- 21 CFR 807.40Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States1 letter cites both
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
Latest letters citing it
The letter citing 21 CFR 801.1 that FDA posted most recently.
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