In a bid to gather feedback for a future draft guidance, the U.S. FDA announced that it will hold a public workshop regarding the difference between servicing and remanufacturing. The workshop, titled “Medical Device Servicing and Remanufacturing Activities,” will take place at the Hilton Washington DC North Gaithersburg Hotel in Gaithersburg, Md., from December 10-11.
“The discussions at the workshop and comments received in the docket will be considered when developing draft guidance as noted in the ‘Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices’ (‘FDA Report on Device Servicing’) in accordance with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,” FDA officials say in a statement.
What’s more, the workshop will also discuss ways medical device servicing and remanufacturing stakeholders can work together—something many in the industry want, FDA officials say.
In mid-May, the agency published the “FDA Report on Device Servicing”—a report that “discussed the continued quality, safety, and effectiveness of servicing of medical devices by original equipment manufacturers and third-party entities,” according to FDA personnel. Feedback and comments from a 2016 open docket and public workshop greatly shaped the report.
“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,” according to an FDA statement.
The report also detailed several actions the FDA plans to take—one of which is distinguishing between servicing and remanufacturing activities. “As described in that report, the FDA intends to publish guidance to assist in differentiating these activities,” the agency says. The feedback from the December workshop, as well as the comments received in the docket, will likely influence the draft guidance, which is on the Center for Devices and Radiological Health’s Fiscal Year 2019 (FY 2019) Program Guidance Development “A-list.”
An FDA White Paper in advance of this meeting raised some interesting and possibly concerning examples that open the question of whether non-OEM parts are “remanufacturing”. However risk assessment should handle most cases. In fact risk assessment might suggest a non-OEM part made the device safer rather than more dangerous.
Scot Mackeil has registered for the workshop, and will also submit comments to the FDA docket. Regarding Mr Hyman’s comment above. Right on! When I refurbished Lab analyzers, I built replacement cable harnesses. The OEM harnesses used insulation displacement connector pins and were a known source of failures in the field as connection deteriorated in the damp saline rich interior of the analyzers. The harnesses I made, I took the additional step of using gold plated pins and soldering the pins after crimping them, analyzers with my cable harnesses never again had failures associated with wiring harness connections. The harness carried voltage and signal to the hemoglobin measuring cuvette lamp and detector. Failures or poor connectivity could impact reported Hgb MCH and MCHC values and affect diagnostic results, this is a perfect example of improvement during refurbishment making a device better and “safer”. All the company’s field reps soon were insisting on putting one of “Scot’s cables” in analyzers they were supporting. I did use an OEM cable as a template to build my cable jig and used all the same connectors and dimensions, I used better materials and better assembly practices. This was my 1st HTM job in 1981… Thanks Dick Davis and Richie Caso for all you taught me in those years !