21 CFR § 808.3 - Definitions.

---
identifier: "/us/cfr/t21/s808.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 808.3 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "808.3"
section_name: "Definitions."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "808"
part_name: "EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360j, 360k, 371."
regulatory_source: "43 FR 18665, May 2, 1978, unless otherwise noted."
cfr_part: "808"
---


# 808.3 Definitions.

*Compelling local conditions* includes any factors, considerations, or circumstances prevailing in, or characteristic of, the geographic area or population of the State or political subdivision that justify exemption from preemption.

*More stringent* refers to a requirement of greater restrictiveness or one that is expected to afford to those who may be exposed to a risk of injury from a device a higher degree of protection than is afforded by a requirement applicable to the device under the Federal Food, Drug, and Cosmetic Act.

*Political subdivision* or *locality* means any lawfully established local governmental unit within a State which unit has the authority to establish or continue in effect any requirement having the force and effect of law with respect to a device intended for human use.

*State* means any State or Territory of the United States, including but not limited to, the District of Columbia and the Commonwealth of Puerto Rico.

*Substantially identical to* refers to the fact that a State or local requirement does not significantly differ in effect from a Federal requirement.

[87 FR 50762, Aug. 17, 2022]