This morning at the FDA's public Workshop on its Mobile Medical Applications Draft Guidance, which it published in July, FDA senior advisor Bakul Patel noted that Medco had registered its smartphone app Medco Pharmacy App as a Class 1 medical device. The app became commercially available in mid-May and marked a collaboration between the pharmaceutical company and Verizon Wireless, which is offering the app in its VCAST application store. The app is also available for iPhone, Blackberry, and Android users.

Patel noted that the app is registered as a Class 1 medical device, which means it is among the lowest-risk medical devices.

Much of the discussion at this week's workshop centered on to what extent medical app developers need to converse with the FDA.

The Medco Pharmacy App has three core features: listings of potentially lower cost drugs, medication tracking and alerts, medication risks alerts, and a prescription ID card.

Vocel, which developed The PillPhone app and received FDA clearance for it back in February 2006, also had partnerships for distribution among the major mobile operators in the US. PillPhone offers some of the same features as Medco's app.

AT&T announced its distribution partnership for WellDoc's DiabetesManager shortly after the company announced FDA clearance for its mobile health service, too.

Sure seems like checking in with the FDA is a prerequisite to get into a mobile operator's pipeline.

CORRECTION: The original version of this article claimed that the FDA had given the Medco app "clearance," however, as a Class 1 medical device the device maker need only register the device with the FDA. No process for "clearing" the device was necessary. Thanks to MedicalConnectivity.com analyst Tim Gee for pointing out the error.