Smart Phone Healthcare & Medical Applications Might Be Medical Devices

I’ve been meaning to write an update on smart phone applications geared towards healthcare and the medical community (here are some previous posts on the subject). During the past few months, there have been literally hundreds (probably thousands) of new medical and healthcare applications for smart phones. As I’ve read about each, I’ve wondered how many are considered medical devices according to FDA’s definition:

“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it’s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

Notice the section in bold. Based on this definition, many of these smart phone applications do in fact meet the FDA’s definition of a medical device. This is interesting, to me, for several reasons:

• How many of these applications have received FDA clearance?
• What about the smart phone platforms? Have they been put through the rigors of electronic medical device testing?
• What about data integrity, software validation, compliance?

I haven’t read much from FDA or other industry experts on this topic–yet. I’m sure we will see more very soon. In the meantime, check out this article from Bio Job Blog “Are Smart Phones Medical Devices?”