The AAMI Software Risk Management Technical Information Report working group has a full draft out for formal comment as of Jan 5, 2004. The comment period ends March 1, 2004. Contact one of the co-chairs if you are not a member of the AAMI committee and would like a copy for comment: Alan Kusinitz Managing Partner of SoftwareCPR at alan@softwarecpr.com or Paul Jones of FDA at pxj@fdadr.cdrh.gov.
If you are a www.softwarecpr.com subscriber you can access a copy for comment in the standards section of the library.