The FDA has released its report “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices” in accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA).
The executive summary of the report states: “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. Although we do not believe that additional, formal regulatory action is warranted, based on the available information and findings, we intend to pursue the following actions:
- Promote the Adoption of Quality Management Principles;
- Clarify the Difference Between Servicing and Remanufacturing;
- Strengthen Cybersecurity Practices Associated with Servicing of Medical Devices; and
- Foster Evidence Development to Assess the Quality, Safety and Effectiveness of Medical Device Servicing.”