Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER V— - DRUGS AND DEVICES › Part Part C— - Electronic Product Radiation Control › § 360ll
Manufacturers must immediately tell the Secretary when they find that an electronic product they made, assembled, or imported has a radiation-related safety defect or, if it was made on or after the effective date of a required safety standard, does not meet that standard — but only if the product has already left the factory. They must also quickly notify known buyers and the dealers or distributors who got the product. Notices to the first buyer and any later owner must be sent by certified mail. Notices to dealers or distributors must be sent by certified mail or a faster method. The notice must plainly explain the defect or noncompliance, describe the hazard, say how the product can be repaired, and tell people they have the right to a free repair, a replacement that meets the standard, or a refund. Manufacturers must give the Secretary a true copy of every notice they send to dealers or buyers. The Secretary can share helpful information with the public but will not release trade secrets except as allowed by law (section 1905 of title 18). A product can also be found unsafe or noncompliant by the Secretary’s testing or review. If a product is found unsafe or noncompliant and notice is required, the manufacturer must, at no charge, either fix it and pay related shipping costs, replace it with an equivalent compliant product, or refund the purchase price, in the way the Secretary’s rules require. A manufacturer who believes the problem poses no significant risk (including genetic risk) can ask the Secretary not to notify buyers; the manufacturer must prove this and can present evidence before the Secretary decides. This rule does not apply to products made before October 18, 1968.
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Food and Drugs — Source: USLM XML via OLRC
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Reference
Citation
21 U.S.C. § 360ll
Title 21 — Food and Drugs
Last Updated
Apr 6, 2026
Release point: 119-73