News Feature | April 2, 2014

Simplify Mobile Device Classification

Katie Wike

By Katie Wike, contributing writer

90% Use Mobile Devices For Work, 20% Receive Security Training For Them

FDA submitted proposal to Federal Register, aims to simplify classifying mobile devices

The FDA released its wireless device guidelines in September focusing on security, maintenance, and monitoring. Now, it has proposed updates to amend its regulations governing classification and reclassification of medical devices to conform to provisions in the FDA Safety and Innovation Act (FDASIA).

"FDA is proposing these revisions to update its regulations to reflect these and other changes, and to ensure classification of devices in the lowest regulatory class consistent with the protection of the public health and the statutory scheme for device regulation," states the proposed rule.

"This proposed rule is a very long anticipated and much needed improvement in the classification and reclassification process," Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, told Health Data Management. "The classification process acts as a sort of gateway to FDA regulation, dictating for a specific, defined category of medical device the regulatory requirements that apply. FDA is supposed to develop classifications for each new type of medical technology so the public knows the associated regulatory requirements. Unfortunately, FDA has fallen behind in developing new classification regulations because creating the classifications takes so darn long and involves an almost endless number of legal hoops the agency has to jump through."

According to iHealth Beat, the rule identifies five categories of devices that would be placed in the lowest regulatory class, including:

  • devices that show uncontrollable known risks
  • devices with an unknown or unfavorable risk-benefit profile
  • devices that require a complete review of manufacturing information
  • devices that must receive a premarket review for any change affecting safety or effectiveness
  • combination products that include a drug or a biological product that must be verified for safety and effectiveness

"It's our hope that by streamlining the classification process and getting rid of some of the needless bureaucratic obstacles, FDA can do a better job of keeping up with these important new technologies, providing clear guidance for the new categories of technology being developed," Thompson added.