21 CFR 807.81
When a premarket notification submission is required
21 CFR 807.81 is the regulation titled “When a premarket notification submission is required” in 21 CFR Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices. Since 2021, 100 FDA warning letters have cited it.
- Letters citing it
- 100 since 2021
- Jan 1 to Oct 30, 2026
- 19 against 20 on the same dates in 2025
- Most often cited with
- 21 CFR 820.30, in 51 letters
- Closed out
- 18% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (97 of 100). 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 807.81 most often, as written in the letters.
- 1 letterFailure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17
- 1 letterFDA has determined that BPI is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to…
- 1 letterFDA's regulations at 21 CFR 807.81(a)(3)(i) provide that submission of a 510(k) is required for "a change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a…
The regulation
Read the text of 21 CFR 807.81 (eCFR, as of Sep 1, 2026)
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria:
(1) The device is being introduced into commercial distribution for the first time; that is, the device is not of the same type as, or is not substantially equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II.
(2) The device is being introduced into commercial distribution for the first time by a person required to register, whether or not the device meets the criteria in paragraph (a)(1) of this section.
(3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification:
(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.
(ii) A major change or modification in the intended use of the device.
(b)(1) A premarket notification under this subpart is not required for a device for which:
(i) A premarket approval application under section 515 of the act, or for which a petition to reclassify under section 513(f)(2) of the act, is pending before the Food and Drug Administration, or
(ii) There is a predetermined change control plan (PCCP) cleared under section 515C of the act, provided that the change is consistent with the PCCP.
(2) The appropriate FDA Center Director may determine that the submission and grant of a written request for an exception or alternative under § 801.128 or § 809.11 of this chapter satisfies the requirement in paragraph (a)(3) of this section.
(c) In addition to complying with the requirements of this part, owners or operators of device establishments that manufacture radiation-emitting electronic products, as defined in § 1000.3 of this chapter, shall comply with the reporting requirements of part 1002 of this chapter.
[42 FR 42526, Aug. 23, 1977, as amended at 72 FR 73601, Dec. 28, 2007; 89 FR 18792, Mar. 15, 2024]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 807.81.
- 21 CFR 820.30Design controls51 letters cite both
- 21 CFR 820.198Complaint files49 letters cite both
- 21 CFR 820.100Corrective and preventive action42 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?27 letters cite both
- 21 CFR 820.50Purchasing controls26 letters cite both
- 21 CFR 820.22Quality audit21 letters cite both
- 21 CFR 820.75Process validation21 letters cite both
- 21 CFR 820.90Nonconforming product18 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 807.81 that FDA posted most recently.
- DevicesView Next Medical Products Company, LLCClear Image Ultrasound Gel, Clear Image Sterile, non-sterile MediChoice Ultrasound Gel, and Clear Image SinglesIssuedAug 19, 2026PostedNov 3, 2026
- DevicesView Pro-Optics, LLCTight Top and Flip Top Contact Lens CasesIssuedOct 5, 2026PostedOct 27, 2026
- DevicesView Chirp Innovations, LLCChirp Halo Wireless Muscle StimulatorIssuedOct 2, 2026PostedOct 27, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.