Some mobile apps for clinical trials--like many healthcare apps--perform the uncomfortable magic of turning a smartphone into a medical device. The puzzler is determining when the app forces the phone across that regulatory line.
FDAzilla blogs that consultancy MDCI and the mHealth Regulatory Coalition see this "complex question" as an area in which the FDA could use an industry assist. The coalition wants to help the regulator spell out what developers need to know before they bring products to market.
It issued a white paper titled Call for Clarity last December that addressed two key questions: What mobile health hardware and software will the FDA regulate? And into which device classification will they be placed?
The document addresses technical, legal and regulatory details. In addition to the phone-turns-into-medical-device question, the coalition seeks FDA guidance on the handling of data stored in a smartphone, as well as that stored in the cloud but used on a mobile device.
- here's the blog
- see the Call for Clarity