Previewed yesterday on FDA’s website, but officially published 21 July, is the Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications. The Guidance Document is printed in the Federal Register (and on the FDA website) for a 90-day period of public comments and suggestions. FDA states that relatively few apps will come under their purview, but the scope is potentially far larger. In FDA’s own words:
FDA is proposing to oversee mobile medical apps that:
- Are used as an accessory to an FDA-regulated medical device. For example, an app could enable a health care professional to view medical images on an iPad and make a diagnosis;
- Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
Bradley Merrill Thompson of Epstein, Becker and the mHealth Regulatory Commission, which has been laboring to influence FDA in this regard, aptly points out in his post on the Continua group on LinkedIn (group membership required) that clinical decision support systems might very well fall under the second point–you may not need to add hardware to make a smartphone into a medical device. For instance, the built-in accelerometer or microphone may be all that is needed, with the right software.
Much comment from many sources, so here is our start of links which will be added to over the next few days.
FDA Draft Guidance document (web), PDF version (30 pages), FDA article/press release. MobileHealthWatch.
Updated 22 July: mHealth Alliance response.