21 C.F.R. § 809.3

Definitions

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(a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.

(b) A product class is all those products intended for use for a particular determination or for a related group of determinations or products with common or related characteristics or those intended for common or related uses. A class may be further divided into subclasses when appropriate.

(d) Act means the Federal Food, Drug, and Cosmetic Act.

[41 FR 6903, Feb. 13, 1976, as amended at 45 FR 7484, Feb. 1, 1980; 89 FR 37445, May 6, 2024; 90 FR 45136, Sept. 19, 2025]

Notes of Decisions

Cited in 4 cases (3 in the last 5 years), 1994–2025 · leading case: United States v. An Undetermined No. of Unlabeled Cases, Etc., Clinical Reference Lab'y, Inc., Claimant-Appellant, 21 F.3d 1026 (10th Cir. 1994).

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United States v. An Undetermined No. of Unlabeled Cases, Etc., Clinical Reference Lab'y, Inc., Claimant-Appellant, 21 F.3d 1026 (10th Cir. 1994). “See 21 C.F.R. § 809.3 (a) (in vitro diagnostic products “intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae”).”

Ass'n for Molecular Pathology v. United States Food & Drug Admin. PURSUANT TO COURT ORDER, DOCKET IN THE LEAD CASE AS DIRECTED. (E.D. Tex. 2025). · cites it 3× “AR7134, 7148 (emphasis added) (proposed amendment to 21 C.F.R. § 809.3 (a)). In the preamble, FDA made clear that it intended this amendment to clarify that all laboratory test services are “devices” and that whenever a laboratory scientist or technician performs a clinical…”

Murphy Med. Assocs., LLC v. Cigna Health & Life Ins. Co. (D. Conn. 2022). “” 21 C.F.R. § 809.3 . equals the cash price for such service as listed by the provider on a public internet website, or such plan or issuer may negotiate a rate with such provider for less than such cash price.”

Murphy Med. Assocs., LLC v. United Med. Resources, Inc. (D. Conn. 2023). “” 21 C.F.R. § 809.3 . ‘‘(A) is approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act (21 U.”

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