Skip to content
LexBuild

21 CFR § 1003.2 - Defect in an electronic product. 

---
identifier: "/us/cfr/t21/s1003.2"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1003.2 - Defect in an electronic product."
title_number: 21
title_name: "Food and Drugs"
section_number: "1003.2"
section_name: "Defect in an electronic product."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "J"
subchapter_name: "RADIOLOGICAL HEALTH"
part_number: "1003"
part_name: "NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY"
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. 360hh-360ss."
regulatory_source: "38 FR 28628, Oct. 15, 1973, unless otherwise noted."
cfr_part: "1003"
---

# 1003.2 Defect in an electronic product.

For the purpose of this part, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if:

(a) It is a product which does not utilize the emission of electronic product radiation in order to accomplish its purpose, and from which such emissions are unintended, and as a result of its design, production or assembly;

(1) It emits electronic product radiation which creates a risk of injury, including genetic injury, to any person, or

(2) It fails to conform to its design specifications relating to electronic radiation emissions; or

(b) It is a product which utilizes electronic product radiation to accomplish its primary purpose and from which such emissions are intended, and as a result of its design, production or assembly it;

(1) Fails to conform to its design specifications relating to the emission of electronic product radiation; or

(2) Without regard to the design specifications of the product, emits electronic product radiation unnecessary to the accomplishment of its primary purpose which creates a risk of injury, including genetic injury to any person; or

(3) Fails to accomplish the intended purpose.