The US Food and Drug Administration has proposed to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers to go through the 510(k) process. The agency made clear the deregulatory move would not necessarily exempt the device makers from other steps like appropriately registering and labeling their wares as medical devices or quality systems requirements. While today's announcement is just a proposal and requires the usual public comment period and so on, the FDA said it would not enforce 510(k) requirements for the devices it listed and it doesn't expect companies making these devices to submit 510(k)s for them in the meantime.
"This is big news, and a huge boost to the [mobile health] industry," the mHealth Regulatory Coalition's Bradley Merrill Thompson wrote MobiHealthNews in an email. "It shows that FDA is being extremely practical in reviewing its own practices, and updating its regulatory requirements where the risks simply do not merit the investment of regulatory resources. My hat is off to FDA."
Among the product codes the FDA listed, a handful are ones that digital health device clearances have used in recent years -- or even recent months. That means fast followers could be in a position to launch sooner with less regulatory constraints, and incumbents may be able to iterate their already-cleared products more quickly.
Thermometers. The FDA has removed 510(k) requirements for clinical digital thermometers, which include smartphone-enabled, peel-and-stick temperature-sensing patches like the one Raiing got clearance for in 2012 and the smartphone-connected thermometer fertility tracking company Kinsa received FDA clearance for earlier this year.
Smart Body Scales. Many of the wireless-enabled weight scales in the market today have 510(k) clearance from the FDA because they offer body fat analysis via impedance, which sends a low-level, electrical zap through the body. iHealth got FDA clearance for its body fat sensing weight scale years ago and Withings got clearance despite commercially launching years before. More recently Fitbit's Aria scale, which uses the same body fat analysis method, finally got FDA clearance in June after more than two years on the market. Now weight scales like these don't need to seek 510(k) clearance.
Stethoscopes. There have been a number of smartphone-connected stethoscope devices over the years, and thanks to today's proposal from the FDA, smartphone-powered devices like the one under development by StratoScientific may not need to seek FDA regulatory clearance now.
Ophthalmic cameras. Smartphone peripherals that turn the device into ophthalmic cameras, like Welch Allyn's iExaminer, also no longer need to seek 510(k) clearance under FDA's draft guidance document. The iExaminer got FDA clearance just last year -- January 2013.
And more... The FDA's full list also includes a number of hearing aid devices and supporting software, which might mean some hearing aid management apps no longer need to go through 510(k). The document could affect the regulatory status of many other digital health devices -- check out the full document over at the FDA's website here (PDF).