21 CFR 890.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
21 CFR 890.9 is the regulation titled “Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)” in 21 CFR Part 890, Physical Medicine Devices. Since 2021, 10 FDA warning letters have cited it.
- Letters citing it
- 10 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 4 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 10 letters
- Closed out
- 30% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (9 of 10). 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 890.9 most often, as written in the letters.
- 1 letterBecause your devices are for different intended uses than legally marketed devices in that generic type of devices of therapeutic massagers regulated under 890.5660, the devices exceed the limitations described in 21…
- 1 letterBecause your devices operate using a different fundamental scientific technology than legally marketed devices in the generic type of devices of therapeutic massagers regulated under 21 CFR 890.5660, these devices…
- 1 letterFDA has reviewed your firm’s website (www.skinsheek.com)***1*** and determined that the CLEAR 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…
The regulation
Read the text of 21 CFR 890.9 (eCFR, as of Sep 1, 2026)
The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:
(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;
(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism directly from clinical material;
(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and
(9) For near patient testing (point of care).
[65 FR 2321, Jan. 14, 2000]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 890.9.
- 21 CFR 807.81When a premarket notification submission is required10 letters cite both
- 21 CFR 820.198Complaint files7 letters cite both
- 21 CFR 820.30Design controls6 letters cite both
- 21 CFR 890.5500Infrared lamp6 letters cite both
- 21 CFR 820.100Corrective and preventive action5 letters cite both
- 21 CFR 820.20Management responsibility5 letters cite both
- 21 CFR 820.22Quality audit5 letters cite both
- 21 CFR 820.50Purchasing controls5 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 890.9 that FDA posted most recently.
- DevicesView Advance-Esthetic LLCZemits CrystalFrax Pro, Zemits Abigon Pro, and Zemits Bionexis Lite ProIssuedAug 25, 2026PostedSep 22, 2026
- DevicesView Technological Medical Advancements LLCDiowave 250 WLS and Diowave 100 WLS laser systemsIssuedSep 26, 2025PostedOct 7, 2025
- DevicesView Spectra Therapy, LLCTherapeutic heating infrared lamps (LASERwrap system)IssuedJul 22, 2025PostedAug 12, 2025
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.