The Food and Drug Administration and the Federal Communications Commission are holding a public meeting Monday and Tuesday to explore whether and how the two agencies should regulate wireless medical devices, including smartphone applications.
"At one end, general-purpose communications devices such as smartphones, wireless routers and certain video-conferencing equipment are regulated by FCC. At the other end, medical devices that critically monitor patient health or provide treatment or therapy are regulated by FDA," the agencies say in a joint statement. "Devices that do provide critical care and also use communications, such as life-critical wireless devices like remotely controlled drug-release mechanisms, are regulated by both agencies. In addition, device applications that would not be governed by FCC but transmit over wireless networks might warrant FDA oversight, while FCC might have better capability to assess the reliability of their communications capability."
The wireless and smartphone industries have been on pins and needles over potential regulation of medical apps since the FDA told Apple to remove an iPhone image viewer called Mobile MIM from the Apple App Store a year and a half ago. Then, in January 2010, the FDA rejected the second attempt by the vendor--Cleveland-based MIMVista--to get fast-track approval of the app.
Millions if not billions of dollars are at stake here. "Not all medical-themed apps will fall under the FDA's purview," reports DOTmed Business News. "While a product marketed to help people lose weight might seem the same as a one designed to help treat obesity, to the FDA, it could mean the difference between giving the product a free pass and requiring extensive pre-release research."
There also may be a culture clash brewing between the freewheeling atmosphere of Silicon Valley innovation and the meticulous, by-the-book FDA regulatory process. "I think there's a cultural problem that the app makers are software companies unused to regulation," Washington, D.C., attorney Bradley Merrill Thompson tells DOTmed. "They're using their old business model of quickly generating new software versions, trying to be first to the market, hoping that theirs will get all the brand recognition." But in the world of medical devices, the first one out with a product often has to spend the most time and money demonstrating that its product is safe.
"That degree of fear of the FDA regulations is putting established companies off from coming into that market," British wireless technology expert Nick Hunn says. "It's causing concern for startups, and perhaps most worrying of all, it's making investors wary of putting money in a company if they have to go through a protracted approval process." Hunn wonders, however, if software companies aren't "crying wolf" over the specter of FDA regulation.