After months of debate, the U.S. FDA is planning to publish a draft guidance document by September 30—which, agency officials say, will help distinguish between medical device servicing and remanufacturing.
Katelyn R. Bittleman, PhD, a consumer affairs officer for the FDA’s Center for Devices and Radiological Health (CDRH), made the announcement earlier this month during the HTM Annual Leadership Exchange (HALE) meeting at AAMI Exchange 2019. This news also came exactly six months after the FDA’s public workshop in Washington, D.C., to delve into the subject.
At the time, CDRH Director Jeffrey Shuren stated that the FDA hoped to accomplish four goals through the workshop: to gauge whether there were “areas or issues that OEMs and [servicers] both believe are important for [facilitating] high-quality servicing and may warrant additional actions to maintain that objective;” to determine if both parties were interested in identifying and implementing those actions together; and, if so, to determine who would participate in the collaboration and who should serve as its convener; and, finally, to establish a time frame for executing the goals.
During AAMI’s HALE meeting, Bittleman addressed some of these questions, particularly the collaboration aspect. Specifically, she said all stakeholders in the HTM sector—original equipment manufacturers, independent service organizations, and in-house HTM professionals—need to come together to establish what the FDA dubs a “collaborative community.” Such an action will go a long way in helping the industry find common ground in the long-time debate surrounding servicing, Bittleman asserted.
Dave Francoeur, senior vice president of marketing and sales for Tech Knowledge Associates LLC, and co-chair of the HALE, shared Bittleman’s views. “The FDA isn’t going to mandate actions on the part of any one stakeholder,” he told attendees of the HALE meeting. “Ultimately, they are looking for parties to come together to determine the best course of action, [and] then FDA can support that strategy going forward.”
Along with distinguishing between servicing and remanufacturing, the FDA is pursuing other service-related actions—moves detailed the May 2018 “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices.”
- Bolstering cybersecurity practices related to medical device servicing
- Encouraging medical device servicers to adopt quality management principles, such as those explained in ANSI/AAMI/ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes.
- Promoting the development of evidence to evaluate the quality, safety, and effectiveness of medical device servicing