The Food and Drug Administration (FDA) has added a month to the deadline for comments regarding the recent public workshop entitled “Medical Device Servicing and Remanufacturing Activities.” The intent of the workshop was 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between medical device servicing and remanufacturing activities to better inform the development of a future draft guidance.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 was also intended to discuss opportunities for collaboration among medical device servicing and remanufacturing stakeholders.
Video recordings of the two-day workshop are currently available online. (Day 1, Day 2)
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 at this time. The FDA Report on Device Servicing also included several actions that FDA intends on pursuing.
Clarifying the difference between servicing and remanufacturing activities is one of the actions outlined in the FDA Report on Device Servicing. As described in that report, FDA intends to publish guidance to assist in differentiating these activities. The discussions at the workshop and comments received in the docket will be considered when developing the draft guidance. This draft guidance is on CDRH’s Fiscal Year 2019 (FY 2019) Program Guidance Development “A-list.”
During the workshop, specific topics outlined in a white paper were discussed.
Comments regarding this issue may be uploaded by visiting the regulations.gov website and should be identified as pertaining to FDA Docket 2018-N-3741. Comments are being accepted until February 25.
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