FDA Releases FDARA Mandated Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices

FDA Releases FDARA Mandated Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices

As part of our commitment to ensuring the continued safety and effectiveness of medical devices throughout their lifecycle, FDA released a report today addressing the critical step of servicing medical devices. 

The report, now available on FDA.gov, discusses the continued quality, safety, and effectiveness of servicing of medical devices by original equipment manufacturers and third party entities. The report was informed by feedback and comments from an open docket and a public workshop held in 2016, among other information. The public workshop included broad participation by original equipment manufacturers, independent service organizations, healthcare establishments, biomedical and clinical engineers, healthcare technology management professionals, and professional and trade associations. Based on the available information, the FDA believes the current available evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices that would justify imposing burdensome regulatory requirements at this time. The report also includes several actions that FDA intends on pursuing.

The FDA published the report as a required provision of the 2017 the Food and Drug Administration Reauthorization Act (FDARA).

Food and Drug Administration
Center for Devices and Radiological Health