Second, FDA does not have sufficient staff to enforce additional regulations. Providing in-depth software validation is a gargantuan task for which FDA appears to have neither enough expertise nor funding. Third, the two agencies have different types of relationships with their respective industries. FDA is a regulator, whereas DOD is a customer. It would be impossible for FDA to require that all medical device software be written in a particular programming language as the miltary has done.
Software development is a complex process, and it gets more complex all the time.
As medical devices rely more and more on software to implement functions and safety features, FDA must place increased emphasis on the use of proper software development methods. I think so. Even though medical device manufacturers could comply with the letter of the law but not its intent, such companies will not survive for long. The complexity of the software required to run tomorrow's medical devices will demand proper software development techniques. Post them in our Members' Discussion Forums .