Jul 19, 2011

Highly anticipated draft guidance on mobile medical applications has been published by the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER).

Targeting specific subsets of mobile medical device applications, the guidance should help answer some longstanding industry questions of how—or whether—US and other regulators would approach such devices. The guidance could furthermore serve as a template for other medical device market regulators determining how to establish requirements for this burgeoning sector of the device industry.

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.

Regulatory requirements manufactures of such devices may need to address depend on their devices’ classifications. According to the guidance, Class I mobile medical devices would have to comply with the following components (General Controls) of the Code of Federal Regulations:

  • Establishment registration and Medical Device listing (21 CFR Part 807)
  • Quality System regulation (21 CFR Part 820)
  • Labeling requirements (21 CFR Part 801)
  • Medical Device Reporting (21 CFR Part 803)
  • Premarket Notification (21 CFR Part 807)
  • Reporting Corrections and Removals (21 CFR Part 806)
  • Investigational Device Exemption (IDE) requirements for clinical studies of investigational devices (21 CFR Part 812)

Manufacturers of Class II mobile devices would need to meet the General Control requirements listed above, as well as Special Controls and, in most instances, Premarket Notification requirements.

Class III device manufacturers would need to meet General Controls and Premarket Approval (21 CFR Part 814) requirements.

The guidance also spells out FDA expectations that mobile medical application distributors will work with manufacturers in the event that corrections and removal actions need to take place.

The FDA plans separate draft guidances to address the following related issues:

  • 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 mobile medical applications for 90 days following publication of the guidance in the Federal Register.


  • Stewart Eisenhart