As required by the Food and Drug Administration Reauthorization Act (FDARA), which became law last summer, the FDA has issued a report on the continued quality, safety and effectiveness of medical devices related to servicing. In short, the agency concluded that there isn’t enough evidence to conclude that there is a public health concern regarding servicing, and thus more regulatory requirements are not yet needed in this area.
“The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time,” FDA states in the report. “Rather, the objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices.” The agency also concludes that most comments, complaints and adverse events (including deaths) that put the blame on inadequate servicing were instead related to remanufacturing. FDA also believes the role of third-party firms to service and repair medical devices is “critical”.
While FDA feels establishing more regulatory requirements related to servicing isn’t necessary, it plans to carry out several related actions, including promoting the adoption of quality management principles, clarifying the difference between servicing and manufacturing, strengthening cybersecurity practices related to device servicing, and promoting evidence development to assess the quality, safety and effectiveness of device servicing.