The Food and Drug Administration Reauthorization Act of 2017 (FDARA), Section 710 requires FDA to report on the continued quality, safety, and effectiveness of medical device servicing. In this case, servicing includes refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device.
On May 18, 2018, FDA issued Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices.
The report concludes that available objective evidence is not sufficient to support a widespread public health concern related to servicing of medical devices that would justify imposing additional/different burdensome regulatory requirements. FDA intends 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 Devices