This was discussed on a long thread in May 2004 at the topica.com site in which I cited some of the FDA links after struggling to put them in a context. http://lists.topica.com/lists/hardhats/read/message.html?mid=910130973
In the use of language about *closed* or *open*, do you mean Title 21 Part 11 ? This part seems to be concerned only with FDA defining under what circumstances it will accept Electronic records in lieu of paper records whenever a given party is submitting data to comply with any regulatory review or approval. This soothes my belief that FDA is not charged with regulating medical record systems in medical practices.... even if viewing any image involves some generic technology (whether it be adjusting ambient light in a room or adjusting pixels on your monitor). I would like to believe that generic technology is not a medical device, at least once the given procedure is completed and archived...and ...I would be disappointed if medical practice did not leverage generic technology while keeping FDA busy with other more critical beats. Here is the link to Title21 Part 11 Do a *Find* on "closed" and "open" and the discussion is not very enlightening....hardly a mandate for FDA to scrutinize medical records software as if record keeping and subsequent access and display of images constitutes a device. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=ebf33225bf8a91b5c943d06831b245ce&rgn=div5&view=text&node=21:1.0.1.1.7&idno=21 Is there another place where FDA discusses the open/closed paradigm which you describe as a *cognitive loop*? Rusty Maynard (from A Forrey) > The FDA has repeated said that the difference of a device from other > non-regulated software is whether its control capability has the inclusion > of an open cognitive loop that precedes the control of a device. In any > particular situation the can be consulted to determine whether this > control criterion has been met. Display software (text or otherwise) that > involves human interpretation is generally considered and open loop. > ------------------------------------------------------- SF.Net email is Sponsored by the Better Software Conference & EXPO September 19-22, 2005 * San Francisco, CA * Development Lifecycle Practices Agile & Plan-Driven Development * Managing Projects & Teams * Testing & QA Security * Process Improvement & Measurement * http://www.sqe.com/bsce5sf _______________________________________________ Hardhats-members mailing list Hardhats-members@lists.sourceforge.net https://lists.sourceforge.net/lists/listinfo/hardhats-members
