News

Some of today's mobile applications are becoming so sophisticated that they stand to transform mobile devices into medical devices — and should be regulated accordingly. Hoping to clarify which mobile applications are expected to adhere to regulations like any other medical device, the FDA has just released a draft guidance document for these "mobile medical applications."

According to the document, a "mobile medical app" (1) meets the definition of "device" as outlined in section 201(h) of the Federal Food, Drug, and Cosmetic Act; and (2) is either an accessory to a regulated medical device, or transforms a mobile platform into a regulated medical device. The FDA recommends that mobile medical app manufacturers follow Quality Systems regulations, and attributes the majority of software-related device failures to design errors — citing one study in which the most common problem was failure to validate software prior to routine maintenance.

Read the full document here.