Poll Says American Consumers Want FDA Regulation of Medical Device Repair

According to a new poll, 77 percent of American consumers think that the FDA should regulate medical device service and repair conducted by either original equipment manufacturers or independent third-party companies.

Survey company The Harris Poll conducted the research among 2,061 adults in February for Patients Rising Now, a patient advocacy group, focusing on efforts to pass “right to repair” legislation. Such legislation would require original equipment manufacturers (OEM) to share intellectual property such as service manuals, passwords and training materials with unregulated repair companies.

Currently, the FDA regulates repair services by an OEM, but it does not have authority over the nearly 20,000 service and repair companies in the United States.

The advocacy group noted that manufacturers contend that compelling the transfer of intellectual property raises serious safety concerns and that handing over intellectual property to independent servicers increases cybersecurity vulnerabilities for hospitals and physician offices.

New York state passed a right-to-repair bill in 2022, a move that device industry group AdvaMed said is wrong for patients and undermines manufacturers’ incentives to innovate, as the legislation “eviscerates intellectual property rights.” Third-party servicers are also not required to follow FDA regulations or report adverse events, AdvaMed noted, endangering patient safety.