Regulators from the U.S. Food and Drug Administration and the U.S. Federal Communications Commission have been touting their wireless innovation programs of late, even getting some plumb press from the Healthcare Information and Management Systems Society (HIMSS) for their efforts last week. But in talking with two individuals seemingly in the know on such matters, they weren't able to find much substance.
Two lawyers who specialize in FDA and FCC regulation, respectively--both of whom asked to remain anonymous to avoid backlash from federal regulators--each scoffed at the federal initiatives' chances of bringing many wireless or mHealth products to market any faster. The programs amount to "little more than window dressing," they said.
The first--the FDA's Medical Device Innovation Initiative--promises a type of expedited review that is supposed to bring federal regulators into the pre-market approval process earlier than the traditional system, shorten the review period by 50 percent and provide a "transparent and predictable path to market," for wireless medical devices.
The problem: It will only benefit a handful of devices per year. "Pre-market approvals affect only 2 percent of the highest-risk devices, and this expedited review would touch less than 2 percent of those," the lawyers said.
The FDA's own statements indicate they'll only consider technologies that 1) treat a life-threatening illness and/or 2) target an as-yet-unmet clinical need. Perhaps an even tougher bar to clear: To qualify, a wireless device must "revolutionize disease treatment, diagnosis, or healthcare delivery," FDA officials say.
The FCC's own wireless initiative will affect plenty of potential technologies, but isn't really a new process, the lawyers said. And FCC healthcare director Kerry McDermott admits the agency won't even have final rules to guide the program for months yet, nor will the initiative really be humming until 2012.
The rules would provide wireless device manufacturers with a special, streamlined license to use wireless test beds to vet their products' reliability, viability, etc.
"It's just an expansion of a existing process," the lawyers said. "There is ample room for manufacturers to test their devices already."
What do you think? Are these programs more style than substance? Or are they just the beginning of something bigger. Let us know. - Sara