The FDA approved ISO 62304 as a recognized software development standard in 2009. Developing Medical Device Software to ISO 62304 gives a nice overview.
Besides providing a globally accepted development process one of the other practical components is the assignment of a safety class to individual software items and units:
- Class A: No injury or damage to health is possible
- Class B: Non-serious injury is possible
- Class C: Death or serious injury is possible
Each classification changes the required documentation for the assigned software.
These standards will become more widely known as the FDA moves to regulate the proliferation of medical applications for personal and home use, most notably software that runs on mobile devices. I’ve discussed this before in When Cell Phones Become Medical Devices. As noted more recently in FDA oversight may extend throughout health IT:
… an FDA director stated flatly: “Under the Federal Food, Drug and Cosmetic Act, HIT software is a medical device.”
Broad FDA oversight at the QSR/62304 level will probably not happen, but change is certainly coming for many HIT companies.
The Elsmar Cove Forum IEC 62304 – Medical Device Software Life Cycle Processes has a lot of discussion on this topic. This is where I found a document checklist that is useful for understanding the process scope:
IEC62304_Checklist.xls (Excel spreadsheet)
UPDATE (9/9/10): IEC 62304 – The Basics