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OEM trade groups may be seeking to expand definition of 'remanufacturing' quickly and quietly

March 23, 2022
HTM Parts And Service
An op-ed by Robert J. Kerwin

As the 2021 Federal Trade Commission (FTC) report to Congress on repair restrictions acknowledged, some medical equipment manufacturers are limiting the availability of diagnostic software and firmware necessary to make repairs.

That situation may soon worsen, if legislation proposed by a manufacturer trade association is filed and approved. This new legislation is poised to redefine, without justification, the term "remanufacturing" to include some activities long accepted as servicing and refurbishing, meaning the activities would not be permissible without FDA approval and compliance with FDA manufacturer registration and regulatory requirements. Some observers think deliberation on this legislation, if filed, could happen as soon as March 30, when consideration of the 2022 Medical Device User Fee Amendments (“MDUFA V”) is expected to take place.

What does this new manufacturer legislation on "remanufacturing" have to do with medical device user fee legislation? In a word: NOTHING. But some stakeholders may be hoping the "Clarifying Remanufacturing Legislation" (and expanded definition of remanufacturing that comes with it) could limit certain refurbishing and servicing activities. These could conceivably include limiting the ability to use some replacement parts which might be otherwise conforming though they originate from a different (and potentially less expensive) manufacturer.

There are other implications from the remanufacturing definition in the legislation reportedly being proffered, including penalizing use of the recently adopted exemption from the anti-circumvention provision of the DMCA to access software necessary to service medical devices and systems, "bypassing technological protection measures", which would be considered remanufacturing.

In this article, I am to outline my understanding of the proposed legislation, if filed, and the impact it could have on medical equipment stakeholders.

Involving Congress when the FDA should have the final word
The possible passage of this new legislation would happen while the medical device industry awaits finalization of the remanufacturing guidance, which the FDA has placed on its "A-list" of prioritized device guidances. In many ways, this legislation would supersede the FDA Remanufacturing Guidance, a fact which may be quite disappointing to the 80-plus equipment service stakeholders who took the time to comment on the guidance, believing their comments would be impactful.


Wayne Webster

"What we have here is a failure to communicate."

March 25, 2022 10:03

I won't proclaim for a minute to be fully informed as to what the OEM's are doing or why they are going after the ISO's with such fervor. I guess the obvious answer is they wish to create a monopoly and somehow maintain their anonymity by doing this through a public trade association, MITA. We all know who belongs to this association. It's no secret. What amazes me is how the OEM's by making this move are shooting themselves in the foot. They, the OEM's, use the ISO's for installations and removals of equipment, for service and service training. When they take over an institution's equipment service, the OEM frequently uses the ISO for multivendor service expertise. They use them for parts and for sale of equipment. The ISO's are the ones who purchase the equipment the OEM's are taking in trade. It appears, "What we have here is a failure to communicate." When will those needing the services of the ISO's within the OEM organizations wake up and speak up? Leave the patient safety and regulation where it belongs with the FDA. Learn how to coexist with the ISO's and at some point recognize by eliminating ISO's you effectively eliminate a necessary resource for new equipment sales, trade-ins, parts and service.

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Wayne Moore

Mr. Kerwin and Bill H.R. 7253

March 30, 2022 10:04

Wrong again Mr. Kerwin, Bill H.R.7253 introduced yesterday does not change or expand the FDA's definition of remanufacturing at all. In the future you may want to actually read a Bill prior to writing an OpEd about it.

17 ‘‘(B) Remanufacturing of any finished device by engaging in any act that could significantly change the performance or safety specifications, or intended use, of the finished device,

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Steven Ford

Amen, Wayne!

March 30, 2022 10:05

You are spot-on that patient safety should be the guiding principle for regulation. The present system permits far too much power in the hands of large OEMs who have very little accountability to the public. We frequently see equipment operating outside manufacturer's specifications that's been exclusively maintained by the OEM. If not for independent organizations in healthy competition with the OEMs, how is the public to be safeguarded? Via clinical inspection by the FDA, for which no mechanism exist? Via accrediotation agencies, who have serious problems of their own?
Policy changes should move in the direction of increased access by independent service providers, not less. We don't accept this near-monopoly in car repairs, which certainly impacts public safety, so why is it acceptable in medical devices?

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