The recent FDA public workshop “Medical Device Servicing and Remanufacturing Activities” held December 10-11 provided a forum for stakeholders to express their thoughts, data, opinion and more. The FDA also encourages comments regarding the workshop and this topic via https://www.regulations.gov, Docket No. FDA-2018-N-3741 by January 25, 2019.
“The intent of this public workshop is to publicly discuss the distinction between medical device servicing and remanufacturing activities to better inform the development of a future draft guidance. In addition, due to expressed interest from members of the medical device servicing and remanufacturing industry, the public workshop is also intended to discuss opportunities for collaboration among medical device servicing and remanufacturing stakeholders,” is how the FDA described the workshop.
On May 15, 2018, FDA published on its website a report entitled “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices” (FDA Report on Device Servicing) in accordance with section 710 of the FDA Reauthorization Act of 2017 (FDARA). The FDA Report on Device Servicing discussed the continued quality, safety and effectiveness of servicing of medical devices by original equipment manufacturers and third-party entities. The report was informed by feedback and comments from an open docket and a public workshop held in 2016, among other information. Based on the available information, the FDA stated the current available evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices that would justify imposing burdensome regulatory requirements. The FDA Report on Device Servicing also included several actions the FDA intends on pursuing.
Published reports indicate that the FDA is once again pushing the idea of “collaborative communities” to address the challenges associated with safe, effective and quality servicing of medical devices as discussed at previous meetings on this topic, including an AQMDS meeting held about two weeks ahead of the FDA workshop.
The creation of these “collaborative community” was first proposed by the FDA in a congressionally mandated report about this issue in May 2018.
AQMDS, AAMI and other organizations continue to support the idea of “collaborative communities” with the expectation that all stakeholders will be able to have their voice heard including individual biomeds, health care facilities, third-party service providers, equipment manufacturers and more.
AAMI President and CEO Rob Jensen offered for the association to host the next public–private forum on the subject, according to the AAMI website.
The FDA is accepting feedback on its whitepaper (docket number FDA-2018-N-3741) at www.regulations.gov until Jan. 25.