I was under the impression that FDA does regulate software in the form of a medical device (US) as follows:
"A [medical] device is any "instrument, apparatus, implement,machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory,which is ... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease ... or intended to affect the structure or any function of the body ..." [Ref: Section 201(h) of the Federal Food, Drug and Cosmetic Act (Act)]. " "Software which meets this definition is (by law) a device subject to applicable FDA medical device regulations (Code of Federal Regulations, Title 21, Parts 800 - 895). Software can be a device by itself (standalone), or it can be incorporated into another device (as a component or part), or distributed separately for use (as an accessory to) with another device. A device software component or a software accessory to a device is itself also a device, and the software is subject to applicable FDA device regulations. Unless otherwise separately classified, FDA regulates components and/or accessories in the same way and to the same degree as the parent device. " The full text as well as exceptions (non-devices) appears at: http://www.fda.gov/cdrh/ost/points.html The Palm platform is not treated any differently any other computing product. Comments are welcome. Mike ----- Original Message ----- From: "Wayne Brandes" <[EMAIL PROTECTED]> To: <[EMAIL PROTECTED]> Sent: Friday, October 19, 2001 1:56 PM Subject: Re: Why has Palm caught on Over Open source > To my knowledge, medical software in general is not regulated by the FDA. > > Wayne Brandes > > Wayne Wilson wrote: > > >In the same way that any software is subject to FDA regulations. > >So, if to accomplish task A on a PC or mainframe computer, you > >need FDA approved software, to accomplish that same task on a PDA > >you will also need FDA approval. > > > > > ------------------------------------------------------ > Wayne Brandes, DO MPH > Director of Healthcare Informatics > American Institutes for Research > Prospect Center > 10720 Columbia Pike > Silver Spring, MD 20901 > [EMAIL PROTECTED] > ------------------------------------------------------ > > > _________________________________________________________________ > Get your FREE download of MSN Explorer at http://explorer.msn.com/intl.asp >
