How does the FDA classify medical devices into Class I, II, and III?
The FDA sorts medical devices into three risk classes — Class I, II, and III — with escalating controls. The class determines the regulatory pathway, including whether a 510(k) notification or premarket approval is required.
The three classes
21 U.S.C. § 360c establishes the classes of devices intended for human use: Class I (general controls), Class II (general and special controls), and Class III (general controls and premarket approval), in ascending order of the controls needed to provide reasonable assurance of safety and effectiveness.
What you file
For most devices, the class drives the submission. 21 CFR § 807.81 requires a premarket notification (510(k)) at least 90 days before introducing the device into commercial distribution, unless an exemption or premarket approval applies.
A citation to watch
A brief might cite 21 CFR § 820.30 for the class definitions. That section is the design-controls rule within the Quality System Regulation; it does not establish the I/II/III classification, so the judge rejects it.
How these citations were verified
Ruled 2026-06-22Every citation in the answer above was submitted to the Kingsfield judge and ruled against the primary-law corpus — Accept, Reject, or Inconclusive, per citation. These are live verdicts, not editorial. Each card shows the verbatim authority text the verdict was rendered against.
Proposition: Medical devices are classified into Class I (general controls), Class II (special controls), and Class III (premarket approval).
“§ 360c — Classification of devices intended for human use. There are established the following classes of devices intended for human use…”
Cite found; proposition supported by the cited text.
Proposition: A premarket notification (510(k)) must be submitted to FDA at least 90 days before introducing a device into commercial distribution, subject to exceptions.
“§ 807.81 When a premarket notification submission is required. (a) … each person who is required to register his establishment … must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction…”
Cite found; proposition supported by the cited text.
Proposition: 21 CFR 820.30 establishes the three-class (I/II/III) risk classification system for medical devices.
Cite found, but the cited text does not support the proposition. 21 CFR 820.30 is the design-controls section of the Quality System Regulation, not the device-classification statute. Regenerate with 21 U.S.C. 360c.
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Connect the Judge See the architectureThis page is legal information, not legal advice, and does not create an attorney-client relationship. Verdicts reflect the cited authority in the Kingsfield corpus as of the verification date shown above.