Since the beginning of this year, there have been clues that the FDA will be heading toward clarification of the complex regulatory issues posed by mobile health devices and software. We have previously reported on testimony and public comments by Dr. Jeffrey Shuren, director of the  FDA’s Center for Devices and Radiological Health (CDRH) alluding to coming guidelines.

Today, the FDA finally released a detailed draft guidance of how it intends to regulate this rapidly exploding sector of mobile medical devices and software.

This is what the Emergo group, regulatory compliance consultants, has gleaned from today’s FDA press release:

The guidance focuses on mobile applications that either function as accessories to medical devices currently regulated by the FDA; transform a mobile communication device into a regulated medical device via attachments, sensors or other medical capabilities; or allow users to input patient-specific data in order to obtain patient-specific results, diagnoses or treatment recommendations for use in clinical settings.

In the same article, the Emergo Group also notes that the FDA plans to separate draft guidances on the following:

  • Wireless safety issues
  • Classification and submission requirements for clinical decision support software
  • How quality systems apply to software
  • Regulation of mobile applications that analyse or interpret data from multiple medical devices

The FDA is accepting written comments on the proposed rules for 90 days.

This is an important milestone in the maturation of mobile health and will eventually provide important guidance to mobile medical software publishers and device manufacturers. In the coming days, iMedicalApps will be publishing a three part series on the past, present and near future of of FDA regulation of mHealth.