FDA at the Center of Huge Gray Area in Establishing Regs for Wireless Health, Execs Say

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healthcare, McCray adds. Yet the advent of information technologies and consumer electronics represent a way to potentially realize tremendous cost savings in medical care.

“The FDA is right in the center of that now,” McCray says. “The FDA is struggling with these issues. They’re supposed to filter products that individuals or patients can’t, because they’re too complex. So they’re trying to evaluate for safety and efficacy.”

The significance of this process in San Diego was evident this morning, as nearly 60 people attended an early morning briefing on the proposed guidelines that included a “Town Hall” conference call with Bakul Patel, policy advisor at the FDA’s Center for Devices and Radiological Health

“People who are in medical devices sector understand that the FDA is a process,” McCray told me earlier. “The issue with wireless health is that we don’t have a track record because it is so new—so that’s where the uncertainty comes from.”

Fox summarized the FDA’s draft guidance before the conference call began. He said the agency plans to assert its regulatory authority over any wireless medical devices or accessories created to control or operate existing medical devices—an electrocardiogram or blood pressure monitor, for example—as well as any mobile apps that transform a smartphone or tablet into a diagnostic or monitoring device that a doctor would use in prescribing patient therapies or in making clinical decisions. The agency does not plan on covering devices that merely record general health information or maintain compendiums of medical information, such as a Physicians Desk Reference.

It soon became clear, however, that an enormous gray area exists in the distinction the FDA wants to draw between wireless devices developed for medical use (which would be regulated) and devices intended for consumer health or fitness (which would go unregulated).

A key factor for the FDA, Fox says, focuses on the manufacturer’s intended use for a particular device and whether it is being used to provide some level of clinical support. A corollary lies in the claims a manufacturer makes about a wireless device, and how the device is promoted or marketed to the public. A device that claims to cure, mitigate, or monitor disease would fall under the FDA’s regulatory purview.

The complexity of the problem, however, became apparent with the first question, when Jim Moon, the chief technology officer for San Diego’s Sotera Wireless, asked: “If I have Apple’s Snow Leopard operating system on my mobile device [with an FDA-approved mobile app], and I upgrade to Lion [Apple’s newest operating system], is that going to invalidate my FDA approval for that app?”

Deepening the uncertainty, John Dobak, a founder and director at San Diego-based Lithera and the former founder and CEO of San Diego’s Innercool Therapies, said a wireless scale used to measure body weight could also be used to monitor a patient for heart failure. “Where is the predicate that changes a weight scale used for fitness to a diagnostic for heart failure?” Dobak asked.

“The FDA is in an environment where they are just not going to be able to control everything,” Fox said. “They’re not going to be able to keep up with the pace of technological advancements.” Still, the agency needs to develop guidelines that make sense in terms of safety and effectiveness.

As McCray put it, the FDA is struggling with these issues.

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Bruce V. Bigelow was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Follow @bvbigelow

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