Medical Devices with False or Misleading Labeling

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 10/16/2023 updates the guidance section including agency contacts, and charge code language. Changes to the import alert are bracketed by asterisks (***). The Food and Drug Administration has warned and/or taken action against a number of companies that have made improper claims about their products' intended use. Some may carry significant health risks. Section 502(a) declares that a drug or device is misbranded if its labeling proves false or misleading in any particular. Section 201(n) states that if an article is alleged to be misbranded because the labeling or advertising is misleading. Then, in determining whether the labeling or advertising is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the ext

Quoted from the “Reason for Alert” section of the FDA page for 80-06, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.