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FDA says sharing device manuals with ISOs does not create cybersecurity concerns

September 01, 2021
HTM Parts And Service

Electronic servicing materials could be more accessible if exemption is allowed
Knowledgeable observers suggest that the practical effect of allowance of this exemption would be to allow owners of medical devices and their authorized agents (i.e., third party servicers), to access and use the electronic servicing materials and perform servicing activities without the threat of legal action under DMCA.

Service materials for radiation emitting devices — A.I.A.T. (assembly, installation, adjustment and testing) — are already mandated to be supplied “at a cost not to exceed the cost of publication and distribution” under 21 U.S.C. §1020.30(g). Notwithstanding, some electronic service materials for basic servicing are not infrequently unavailable (behind the TPMs) unless a servicer obtains a key from a manufacturer. In any event, there may well be expense and other challenges to get the key. Hence, allowance of this exemption by the U.S. Copyright Office may greatly assist owners of medical devices and third-party servicers working on the devices.

U.S. Copyright Office hearings held to consider new possible exemptions and renewals
Earlier this year, on behalf of IAMERS, I testified in support of the proposed new exemption at the Register’s hearing together with Steve Inacker, president of Avante Health Solutions, and others. Comments had been received in opposition and some testimony mischaracterized in my view some of the supportive underpinnings of the favorable 2018 FDA Servicing Report. I noted that the FDA MAUDE reports (manufacturer and user facility device experience reports) confirm that under one percent of adverse events have been reported with respect to device servicing activities as described more fully in the FDA report.

During his testimony, Inacker acknowledged the proverbial "elephant in the room" with regard to the adverse effects to the patient if a manufacturer imposes the current prohibition against circumvention: “[w]e need to have the right to repair the equipment for our customers and have access to do so on a readily available basis. This is a patient safety issue. When we can’t get access to the equipment that we need to service, patients wait.”

U.S. Copyright asks FDA to weigh in
Faced with comments in opposition to the proposed exemption and claims that the FDA’s regulatory authority may be applicable, the Register of Copyrights made the FDA aware of the U.S. Copyright Rulemaking proceeding.

On August 13, 2021, the FDA Office of Strategic Partnerships and Technology Innovation issued a letter to the U.S. Copyright Office acknowledging that opponents of the exemption have expressed concerns that the exemption may facilitate device servicing by unregulated entities with the potential to increase cybersecurity risks and result in harm to both patients and providers. The FDA noted in this regard that “device servicing entities may be well positioned to help identify and address security vulnerabilities, and observes that ISOs may play an important role in maintaining the overall quality, safety, and efficacy of medical devices.“


Tim Martin

Like the article

September 03, 2021 11:03

Good article.

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Wayne Webster

It's abut time

September 07, 2021 02:32

Glad to see that regulatory bodies can step away from the many claims made by manufacturers and address the issues straight on. We don't know where it will all end but, there seems to be a possibility for a rational outcome.

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Peter Pohli

Still a missing link remains.

October 05, 2021 10:39

The Triennial Rulemaking Proceeding appear to be a hopeful step in the right direction, but I continue to be baffled by the silence in the laboratory instrument service arena.
There is clear headway being made in the right-to-repair movement of consumer, automotive, and agricultural products, spearheaded by the efforts of repair.org and other similar organizations. In the medical instrument field, IAMERS is doing a similar good work for the benefit of patients, consumers, and ISOs. Caught in the void between the two, is the laboratory service industry.
While laboratory instrument service and repair stretches its reach a little into both the other categories, there are many manufacturers who feel they are exempt from either of these two categories and blatantly snub their noses at ISOs, right to repair legislation, and anything else that doesn't maximize their bottom line, no matter how unethical it may be. For example, one manufacturer of cryostats used to sell their service manual for about $4000 per manual per model. (Already outrageous.) When my company finally decided we needed to buy one, we were told that "the FDA no longer allows the sale of the service manual." (A bald-faced lie, at best.) Many other companies don't even try to hide behind a lie and will simply tell you that they only allow their in-house technicians to service their instruments.
My search continues for an organization who actively represents this gap. It would seem that government agencies should embrace supporting ISOs for laboratory instrument servicing, since so many of them are also victims of this abuse by scrupulous manufacturers. Everything from colleges and universities to OSHA and environmental testing labs all end up overpaying for service when OEMs refuse to support ISOs. If anyone is aware of such an organization, I would love to know about it!

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