FDA withdrew recognition of this standard in May 2007 after it was obsoleted and replaced by ISO 62304.
On Jan 14, 2002 FDA issued an update to their list of recognized standards for use by the Office of Device Evaluation. A new software standard was recognized. This is the AAMI/ANSI SW 68 Medical Device Software Life cycle Processes.
The recognition statement indicates the reduction in software submission documentation for companies that conform to the standard and is at the link provided.
Conformance to SW68 eliminates most of the software documentation requirements in the FDA software submission guidance for minor and moderate levels of concern software except for the software description, hazard analysis, requirements, and release version number. In comparison to other software standards recognized by FDA it is the only standard that eliminates the need to submit a bug list and revision history.
For major level of concern software it eliminates the need for development process information only.
Subscribers to SoftwareCPR.com can get more standards recognition information and a visual aide comparing the different recognized software standards in our library.