A manufacturer of cochlear implants has agreed to pay a major financial penalty for falsely claiming that its U.S. Food and Drug Administration (FDA)-approved product complied with the requirements of an industry standard.
According to an article posted to the MD+DI Qmed website, Advanced Bionics and the U.S. Department of Justice reached an agreement in December 2022 for the company to pay $12 million for stating in an FDA pre-market application that its medical devices complied with the requirements of CISPR 11, “Industrial, Scientific and Medical Equipment – Radio-frequency Disturbance Characteristics – Limits and Methods of Measurement.”
Specifically, the company reportedly submitted to the FDA positive results from testing to CISPR 11 requirements to support its claims of safety and efficacy, even though Advance Bionic test engineers knowingly rigged the standard’s test procedures to falsely show compliance with the standard’s requirements.
Compliance with CISPR 11 is not a requirement for FDA approval. Nonetheless, the company’s fraudulent representations in its FDA submittal put reimbursement under federal healthcare programs at risk of being deemed fraudulent as well. Legal action brought by an anonymous whistleblower under the U.S. False Claims Act (FCA) was reportedly the basis for the DOJ’s subsequent investigation and the resulting financial penalty.
