FDA: Software Failure Behind 24% of Last Year's Medical Device Recalls

[Marc]

From a /. Discussion - FDA: Software Failure Behind 24% of Last Year's Medical Device Recalls

"Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the U.S. Food and Drug Administration's (FDA's) Office of Science and Engineering Laboratories (OSEL). The absence of solid architecture and 'principled engineering practices' in software development affects a wide range of medical devices, with potentially life-threatening consequences, the FDA warned. In response, FDA told Threatpost that it is developing tools to disassemble and test medical device software and locate security problems and weak design."

[Ronen E]

I thought that's what IEC 62304 was all about -- structuring medical devices software development. IEC 62304:2006 is a FDA recognized standard.

[c.mitch]

I wonder if FDA can disassemble software. Sounds like a copyright infrigement. Sure feds should have this power. However, do they have to notify manufacturers prior to do so ? Any ideas ?