21 CFR 807.20
Who must register and submit a device list?
21 CFR 807.20 is the regulation titled “Who must register and submit a device list?” in 21 CFR Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 3 letters
- Closed out
- 33% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 807.20 most often, as written in the letters.
- 1 letterAs of this date, our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2022
The regulation
Read the text of 21 CFR 807.20 (eCFR, as of Sep 1, 2026)
(a) An owner or operator of an establishment not exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or subpart D of this part who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use shall register and submit listing information for those devices in commercial distribution, except that registration and listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments. The term “device” includes all in vitro diagnostic products and in vitro diagnostic biological products not subject to licensing under section 351 of the Public Health Service Act. An owner or operator of an establishment located in any State as defined in section 201(a)(1) of the Federal Food, Drug, and Cosmetic Act shall register its name, places of business, and all establishments and list the devices whether or not the output of the establishments or any particular device so listed enters interstate commerce. The registration and listing requirements shall pertain to any person who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use, including any person who:
(1) Initiates or develops specifications for a device that is to be manufactured by a second party;
(2) Sterilizes or otherwise makes a device for or on behalf of a specifications developer or any other person;
(3) Repackages or relabels a device;
(4) Reprocesses a single use device that has previously been used on a patient;
(5) Acts as an initial importer as defined in § 807.3(g), except that initial importers may fulfill their listing obligation for any device for which they did not initiate or develop the specifications for the device or repackage or relabel the device by submitting the name and address of the manufacturer. Initial importers shall also be prepared to submit, when requested by FDA, the proprietary name, if any, and the common or usual name of each device for which they are the initial importer;
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.
(b) Registration or listing does not constitute an admission or agreement or determination that a product is a device within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act.
(c) Registration and listing requirements shall not pertain to any person who acts as a wholesale distributor, as defined in § 807.3(t), and who does not manufacture, repackage, process, or relabel a device.
(d) Owners and operators of establishments or persons engaged in the recovery, screening, testing, processing, storage, or distribution of human cells, tissues, and cellular and tissue-based products, as defined in § 1271.3(d) of this chapter, that are regulated under the Federal Food, Drug, and Cosmetic Act must register and list those human cells, tissues, and cellular and tissue-based products with the Center for Biologics Evaluation and Research on Form FDA 3356 following the procedures set out in subpart B of part 1271 of this chapter, instead of the procedures for registration and listing contained in this part, except that the additional listing information requirements of § 807.26 remain applicable.
(e) Owners and operators of establishments that manufacture devices licensed under section 351 of the Public Health Service Act as well as licensed biological products used in the manufacture of a licensed device must register and list following the procedures set out in part 607 of this chapter, instead of the procedures for registration and listing contained in this part.
[77 FR 45941, Aug. 2, 2012]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 807.20.
- 21 CFR 807.81When a premarket notification submission is required3 letters cite both
- 21 CFR 801.1Medical devices; name and place of business of manufacturer, packer or distributor1 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 803.20How 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 807.3Definitions1 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
Latest letters citing it
The 3 letters citing 21 CFR 807.20 that FDA posted most recently.
- DevicesView Ostar Beauty Sci-Tech Co Ltd.3 Levels Injection Insulin Gun Hyaluronic Acid Skin Injection Needle Free Pen; Powered LED Microneedling Device Rechargeable Dermapen for…IssuedDec 4, 2023PostedMay 28, 2024
- DevicesView Sol-Millennium Medical, Inc.sterile and non-sterile syringes and needles intended for aspiration and injection of medications and fluids into the bodyIssuedMar 18, 2024PostedMar 19, 2024
- DevicesView Flawless Beauty and SkinRelumins Premium Derma Pen, Relumins Premium Derma Pen Plus, MESOpower pen and needle modules, Relumins Branded 35 needle Dermastamper,…IssuedAug 5, 2022PostedOct 4, 2022
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