If anyone thinks that the International Special Committee on Radio Interference (CISPR) standards are not relevant when it comes to United States product marketing, they should think again. On December 20, 2022, the Department of Justice (DOJ) announced a $12 million monetary settlement with Advanced Bionics, a manufacturer of FDA-approved cochlear implants, for falsely claiming that one of its products complied with CISPR 11 standards. Interestingly, CISPR 11 compliance is not a legal prerequisite for FDA approval or for US marketing of medical devices generally, including cochlear implants. So how does DOJ justify a monetary penalty for failure to comply with a voluntary CISPR standard?
First, a little background. To access the US healthcare market, an electronic medical device manufacturer must demonstrate compliance with a number of technical standards including, among others, the electromagnetic compatibility limits set forth in the Federal Communications Commission’s (FCC) Part 15
and Part 18 rules. To access most foreign healthcare markets, manufacturers must demonstrate electromagnetic compatibility (EMC) compliance with CISPR 11 limits that are similar, but not identical to, FCC rules. Typically, for purposes of worldwide marketing, healthcare manufacturers will “kill two birds with one stone” by testing for both FCC and CISPR compliance and including both sets of test reports in their product marketing applications.
In the US, medical devices are approved — or...
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