CFR section
21 CFR 1005.3: Importation of noncomplying goods prohibited
PART 1005-IMPORTATION OF ELECTRONIC PRODUCTS · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 1005.3 |
|---|---|
| Section | Importation of noncomplying goods prohibited |
| Part | PART 1005-IMPORTATION OF ELECTRONIC PRODUCTS |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR J Radiological |
| Product types cited | Devices |
| Regulation text (excerpt) | The importation of any electronic product for which standards have been prescribed under section 534 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360kk) shall be refused admission into the United States unless there is affixed to such product a certification in the form of a label or tag in conformity with section 534(h) of the act (21 U.S.C. 360kk(h)). Merchandise refused admission shall be destroyed or exported under regulations prescribed by the Secretary of the Treasury… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.