The Medical Imaging & Technology Alliance (MITA) has responded to the publication of the U.S. Food and Drug Administration (FDA) draft guidance entitled “Remanufacturing of Medical Devices.” The FDA notes, “This draft guidance document is being distributed for comment purposes only.”
“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,” said 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Importantly, the ultimate success of this draft guidance depends on the FDA having a proactive plan to educate, surveil and enforce its provisions and recommendations. Without a robust implementation and enforcement plan, including knowledge of all medical device servicers via registration, the FDA draft guidance will fall short of its objectives.
“The FDA remanufacturing guidance underscores the need for the agency to provide clarity around whom this draft guidance applies, what surveillance mechanisms are available to FDA to detect servicers who are performing remanufacturing activities and how this guidance will be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,” noted 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.”
The draft remanufacturing guidance was published in response to the May 2018 FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices in which the FDA stated that “a significant portion of the comments, complaints, and adverse event reports alleging inadequate servicing pertain to activities more accurately described as remanufacturing.”
Even though MITA views this guidance as a positive development, “it is still a reactive approach to the many examples of poor third-party servicing and/or remanufacturing original equipment manufacturers have been called in to fix in the past,” MITA states in a press release.
“Given the findings of the 2018 FDA report, MITA remains concerned that the majority of third-party servicers are actually engaging in unaccountable remanufacturing activities that are not yet in view of the FDA,” added Hope.
MITA looks forward to working with the FDA to finalize its remanufacturing guidance and urges the agency to move quickly to address the other action steps they committed to taking in their 2018 report, including promoting the adoption of quality management principles, strengthening cybersecurity practices associated with servicing and fostering evidence development to assess servicing.
“The FDA needs data to reach conclusions and take action based on the 2018 recommendations. By refusing to register with the FDA, third-party service businesses continue to thwart the agency’s work – thereby increasing risks for patients, physicians, and technicians,” Hope concluded.
To read the full draft guidance document, download it at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/remanufacturing-medical-devices. It includes examples of work and which are considered are considered remanufacturing. Another link to view the downloaded draft guidance is https://www.fda.gov/media/150141/download.
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