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May 18, 2018

FDA Releases Quality, Safety, and Effectiveness of Servicing of Medical Devices Report

The FDA released a report on May 15, 2018 discussing the continued quality, safety, and effectiveness of servicing of medical devices (including equipment used in radiology and radiation oncology) 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.

Read the full FDA report »