Medical Device, FDA, Regulatory ChangesMarti Rae
FDA Rejects Push for New Regulatory Action on Medical Device ServiceAll news found on aami.org
Posted May 15, 2018
The Food and Drug Administration (FDA) has concluded that there is insufficient evidence to justify imposing additional regulations on third-party servicers of medical devices. The announcement came this morning with the publication of a highly anticipated report on the quality, safety, and effectiveness of medical device servicing that was required as part of the FDA Reauthorization Act of 2017. “We believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices, including by third-party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time,” the FDA wrote in the report. Despite this lack of evidence, the FDA said it does not intend to extend medical device reporting requirements to third-party service providers or require registration by such entities. “We do not believe this information alone would address the outstanding fundamental questions regarding the quality, safety, and effectiveness of servicing,” the FDA stated in the report. Some original equipment manufacturers had pushed the FDA for expanded regulatory oversight in this area, saying there have been significant problems with the quality of service by some third-party servicers, an assertion vigorously rejected by those vendors. Although the agency does “not believe that additional, formal regulatory action is warranted,” it did provide a list of actions it intends to pursue. These are:
- Promoting the adoption of quality management principles, including new and existing quality management standards and best practices.
- Clarifying the difference between servicing and remanufacturing through future guidance that will allow for “more consistent interpretation and categorization.”
- Strengthening cybersecurity practices associated with the servicing of medical devices.
- Fostering a multi-stakeholder approach to evidence development to assess the quality, safety, and effectiveness of medical device servicing.