The US Food and Drug Administration (FDA) has for the first time written to a company because it needs regulatory clearance for a mobile health app.
The FDA has been in touch with Biosense Technologies, the company behind an urinanalysis app called uChek which is designed for the iPhone.
The agency said the app can be considered a device on the basis of its automatic analysis of urine strips. A device that performs such an action needs approval from the FDA.
The agency issued draft guidance in how it proposed to regulate mobile health apps back in July 2011 but has since failed to follow up with final proposals.
A spokeswoman for the agency told Bloomberg that final guidance will be issued later in 2013.
Mobihealthnews raised the question of “does this FDA letter reflect a new trend by the agency or is this likely to be a one-off event?” The writer answers by saying it is unlikely that the FDA “is now embarking on an enforcement campaign against violative mobile apps, at least until the final guidance is out”.