Is FDA's 510(k) rigorous enough for mHealth?


Those of you who are observers of the U.S. Food and Drug Administration know the important role the 510(k) process has come to play in the regulation of mobile health technologies. Over the past decade, the FDA has cleared more than 100 mobile medical applications through the 510(k) process, of which about 40 apps were approved in the past two years alone.

The apps that have been reviewed and cleared fall into the category of Class II devices including remote blood pressure, heart rhythm, and patient monitors, as well as smartphone-based ultrasounds, EKG machines, and glucose monitors. The FDA encourages mobile medical app developers to search the agency's 510(k) Premarket Notification databases to help determine the level of regulation that may be applicable to specific devices or functionalities when they apply for review and clearance.

A 510(k) is a premarket submission made to the regulatory agency to demonstrate that a device that is to be marketed is safe and effective. In a nutshell, a mobile medical app manufacturer need only show the FDA that a new product is "substantially equivalent" to one already on the market. However, potential problems with the 510(k) process arise from the fact that it does not require clinical trials and is the least stringent of the FDA's device approval pathways.

Not surprisingly, a 2011 study published in the Archives of Internal Medicine (now called JAMA Internal Medicine) showed that most medical devices recalled during a five-year period for "serious health problems or death" had been cleared by the FDA using the 510(k) process. The study reported that of the 113 high-priority recalls initiated by the FDA from 2005 to 2009, more than two-thirds involved 510(k) devices. In a few cases, the devices had actually been deemed so low-risk that they did not need FDA regulation. 

"The 510(k) process was specifically intended for devices with less need for scientific scrutiny, such as surgical gloves and hearing aids," argue the authors of the study. "One reason that the FDA has relied heavily on the 510(k) process is because it is less expensive and enables the relatively small Center for Devices and Radiological Health (CDRH) to review thousands of devices each year."

However, the FDA's CDRH needs to put patient safety first regardless of the time, cost and complexity of a more stringent Premarket Approval (PMA) process. Granted, with literally thousands of mobile medical apps currently available on the market or in development, it's no wonder the CDRH has embraced the 510(k) process when it comes to mHealth. How else would the resource-constrained agency be able to handle the coming tsunami of app reviews in a timely manner?

CDRH officials like to boast that, despite a statutory timeframe cycle of 90 days for technologies that come to the FDA for 510(k) premarket clearance, they have only taken about 67 days on average to review mobile medical apps. Back in March, Christy Foreman, director of the Office of Device Evaluation at CDRH, testified before Congress that "all mobile apps we have seen thus far have been in the 510(k) process," a trend she believes will continue at FDA for the foreseeable future. 

Nevertheless, now that the FDA has issued its final guidance on mobile medical apps emphasizing that it intends to "exercise enforcement discretion" (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) even for those apps that may meet the definition of a medical device, it behooves the agency to reevaluate FDA procedures and oversight of mHealth. In recent years, a more aggressive approach to the regulation of medical devices could have prevented them from getting through a lax 510(k) process that only resulted in product recalls. Let's not repeat the same mistakes of the past. - Greg (@Slabodkin)