The Medical Imaging & Technology Alliance (MITA) has responded to the publication of the U.S. FDA’s guidance titled, “Remanufacturing of Medical Devices.”
“The guidance takes a step in the right direction by describing measures all servicers and manufacturers should take to ensure medical devices are functioning properly,” says Patrick Hope, executive director of MITA. “By detailing the importance of conducting risk analysis, ensuring proper documentation and education around remanufacturing and servicing, it is our hope that those entities performing unregulated and unaccountable third-party servicing can obtain a better line of sight into their work and regulatory responsibilities, especially when it veers into remanufacturing, which is often the case.”
Importantly, the ultimate success of this guidance depends on the FDA having a proactive plan to educate, surveil, and enforce its provisions and recommendations, MITA says. Without a robust implementation and enforcement plan, including knowledge of all medical device servicers via registration, the FDA guidance will fall short of its objectives, MITA officials assert.
“The FDA remanufacturing guidance underscores the need for the agency to provide clarity around to whom this draft guidance applies, what surveillance mechanisms are available to FDA to detect servicers who are performing remanufacturing activities and how this guidance will be enforced,” says Hope. “MITA strongly believes all servicers and manufacturers should proactively adopt quality control measures to meet the same quality and safety standards. This can be assured by requiring servicing entities to register with the agency, report errors and demonstrate they have quality management systems in place. Patients deserve nothing less.”
Do you agree with MITA’s assessment? Why or why not?