Medical Device Daily Washington Editor
FDA has routinely regulated the devices that transmit data from patients at home to their doctors' offices, and the agency has recently issued 510(k) clearances for devices that convey blood glucose measurements. However, the market for cell phones that could serve as transmission devices for cardiac electrophysiology equipment is likely to feel the effect of a tougher regulatory process, according to a regulatory attorney.
Brad Thompson of Epstein, Becker & Green (Washington) told Medical Device Daily that recent approvals of such equipment for blood glucose meters involves a bridging device that conveys data from the meter to the phone and hence allows the phone to avoid tight regulatory scrutiny. However, an errant reading of blood glucose is not likely to carry the risks entailed with readings from implantable cardioverter defibrillators, for instance. Thompson said that one bridging device is seen as an accessory to the meter and is "a very small piece of hardware that bridges two articles and was cleared with a pretty broad claims" as to compatible cell phones.
The word "accessory" provides a key distinction where FDA is concerned. Thompson's blog notes that anything that is a component of the device is "owned" by the device maker in regulatory terms, but might be the subject of little more than a materials standard. A cell phone in this instance is definitely an accessory, which is directly regulated, but when used to track a condition that could result in sudden cardiac death – which leaves the patient no room for mistakes – the cell phone becomes an utterly critical accessory, thus upping the stakes.
On one hand, Thompson states, the maker of a cell phone designed to interface with electrophysiology equipment could attach a label with broad claims about data transmission and presumably escape tight scrutiny. A generic claim, he said, might be that the device is "in conformance to a set of standards that describes a broad range of medical products generally." In that situation, however, the device maker – and implicitly the patient – is left with little reassurance that the cell phone would work sufficiently well to pass regulatory muster.
Thompson said the question of how to regulate the software in such a phone is "similar to what FDA faces with other ubiquitous software that is frequently used in medical applications," such as productivity software and operating systems. "FDA is not tempted to knock on Microsoft's door to say we need oversight of Vista," he remarked, so cell phone firms need not worry about such ground-floor scrutiny. The agency typically requires users to validate the use of the software. A cell phone manufacturer's claims are where the action will be. Upon the construction of a claim, "you'd see FDA say that you took that burden onto yourself," he noted.
This all raises the question of what sort of circumstances would have to prevail to prod a cell phone firm into the market. Thompson said that if a cell phone company decided to tweak its software to mesh better with an ICD, "you could imagine a collaboration between the two" for marketing purposes.
"There is a lot advantage" to be obtained by both parties in such an arrangement, Thompson said. "They could sell more cell phones and medical devices," by co-promoting their offerings as a synergistic improvement over their respective rivals' offerings. "If consumers want it, the company that can enter that market by overcoming the regulatory hurdles has a huge advantage."
The cell phone's hardware components might face less scrutiny than the software, but Thompson said that electronic components that qualify under ISO 9001 would not suffice. A company may have to purchase components cleared under ISO 13485 in order to get to market. The use of such components, he said, "goes a long way not by itself all that FDA needs to bringing a company" into compliance.
Thompson pointed out that a clinical trial as such might not be the right environment for testing out the interaction between a cell phone and a piece of hardware in the patient's chest. "If they're showing only that the hardware and the software just convey data, there's no need for clinical trial data," he said, remarking that field testing might suffice. However, such testing would have to demonstrate that the combination works in a nearly foolproof fashion, a requirement that would extend to the cell phone's user manual.
"They would have, to by design and by instruction, make it as failsafe as possible," including helping the patient make sure the cell phone is switched on when the patient leaves home, Thompson said.
Thompson also indicated that a cell phone that actively polls the device for data would be subject to greater requirements than one that passively accepts data and sends it along. The safety data requirements for the former might have to include an evaluation of the risk that the interaction "could inadvertently shut the device off."
The question of liability in the event – some would say the eventual certainty – of a failure of the cell phone to transmit the data would be somewhat complicated, Thompson noted, but not utterly intractable. Cell phone makers would have to charge more for their equipment in part to cover their share of those risks, but "if they can pass that cost on to consumers, they can stay in the market," he said.
The larger question, however, is how a plaintiff's attorney would proceed. The strategy, Thompson said, might be "to sue everyone who could be at fault," and let the defendants make their cases. However, the partner companies could agree to "contractually apportion the risk" between the two firms, he said. Such an arrangement might require negotiations that "could be very contentious" given the magnitude of the risk, and "whoever stands to gain more will have to pay more," he said.
On the other hand, Thompson pointed out that device makers have a better understanding of liability law, and the device maker's greater familiarity with the relevant branch of liability law would almost surely force it to assume the greater share of liability.
Mark McCarty, 703-268-5690;email@example.com