One of the last and liveliest sessions at TEPR+ last week was a presentation and Q&A with Don Witters from the FDA Center for Devices and Radiological Health. Witters repeated multiple times that he attended the show in order to begin a dialog with the mHealth industry to establish clear pathways and regulations that ensure wireless quality of service, coexistence with other medical systems, data integrity, security and electromagnetic compatibility. Witters said his goal was safe, secure and reliable deployments of wireless technology in healthcare.
What is a medical device?
"So, what is a medical device?" Witters asked. "This is an implementation, product, apparatus or other component or accessory, which is used in the diagnosis, cure, mitigation, treatment, prevention of disease or effects any structure of the body--that could actually include some information technologies and performance technologies--but usually it's something that is performed on the patient, touches the patient or is performed between physician and patient."
iPhones with diagnostic apps are medical devices?
At times during the session, the tension in the room was palpable. Witters declared that the FDA has jurisdiction over any device that diagnoses, treats or prevents a disease. This led to one question from the audience: "So an MRI app for an iPhone is a wireless medical device? Or a patient reporting their blood glucose level by text messaging their physician who then adjusts their insulin dosage with a return SMS?" Witters initial response was "No, I think that's getting into information exchange--that's different." After the questioner thanked him and said that people probably just breathed a sigh of relief, Witters doubled-back. "Well, I think the real answer is 'We don't know.' That's why I'm here today to begin this dialog and see where [the FDA] fits." So, the FDA could really be interested in inspecting iPhones for use as "wireless medical devices"? You bet.
If it connects to a phone does the FDA look at the phone too?
Following the question, mobihealthnews asked Witters about a blood glucose monitoring device that recently gained approval by the FDA--the module connects to Motorola's RAZR phone via the USB port. The company also recently told me it had plans to alter the module so it fits into an iPhone, too. Witters noted that he had heard of the recently approved device, but he wasn't on the team that actually approved it so he didn't know whether they inspected the RAZR as part of the wireless medical device system. If it was him, Witters said he would have looked at the RAZR.
Time to discuss standards is now
"I don't think anyone in this room," Witters said, "including myself, knows what the clear pathways are from a concept, to design, to testing, to deployment and maintenance for these systems. There are pieces that the FDA can weigh in on and then there are places that we don't. There's not even a good definition of a standard."
Witters said that the real role of the FDA is to provide some reasonable assurance of safety and effectiveness in medical devices marketed in the U.S. The key point there is "marketed" in the U.S. This does not effect, and is not intended to, direct medical care for physician care directive.
We're the FDA not the IRS
"When it comes to the FDA people think of us more like the IRS," Witters said. "You don't talk to the IRS unless they call you and then you call your lawyer or accountant or somebody. That's not really the way systems work or ought to work. It should be a much more open process. It goes over the edge, though, when you start marketing [an unapproved wireless medical device] and it's a money-making proposition and it has real issues with it. That's where bad things start to happen."
Witters encouraged all mHealth applications developers and wireless medical device makers to the FDA to weigh-in on how the industry should be regulated. Certainly better now than later.