The FDA has just published a new draft of guidance about mobile technology in FDA-regulated systems. This guidance is open for comment and isn’t binding yet.
So, what does this mean for testing FDA-regulated products with mobile technology?
The draft guidance defines when mobile platforms are considered as part of a regulated system or not. The criteria for inclusion of a mobile endpoint seems to be that if it supports a feature which is regulated and the endpoint is an essential part of the system, then the mobile endpoint is also regulated. I don’t see anything in the guidance that calls for a different approach to developing, verifying, or validating FDA regulated system products.
I think the FDA has gotten the general requirements for developing high reliability software-intensive products about right, but the onus for achieving this high quality is on development organizations. There is wide variation in interpretation of these requirements, which can lead to inadequate development practices. See my post Competent, Mediocre, or Dangerous for that story.
I don’t see any essential difference in the general requirements for developing high quality systems with mobile endpoints. However, verification and validation (as understood by the FDA) of a system with mobile endpoints is more difficult than a wired client/server system, other things being equal. Many assume that mobile endpoints are easier to develop/test, but mobile apps and endpoints introduce new challenges for developers, as I explain in Déjà vu All Over Again – The Mobile Testing Nightmare.
To be safe, developers of FDA-regulated systems with mobile end-points will have take the unique challenges of mobile technology in to account as well as achieving overall V&V competency at system scope.