Any form of software that qualifies as a medical device is regulated by the FDA. The definition of a medical device is ambiguous, so if you have questions it would be good to research it thoroughly before assuming it isn't. The general yardstick (disclaimer - I am not a lawyer, this is not a legal opinion!) is whether the device (software in this case) makes decisions or suggests courses of treatment using data or algorithms not readily apparent or easily verified by a trained, competent clinical user, or if the device is an accessory for another device that is subject to regulation. Also - the medical device regulations only apply to distributed device (not commercially distributed - distributed). If you write something for use in your own practice, you are not subject to medical device regulation. If you give it to anyone else, you have distributed it and are subject to regulation. The FDA includes making the software available for download in their definition of distribution. Some exceptions are available for research and clinical trial uses. Examples of software that are or have been subject to FDA actions: Blood Bank software - if used in any way for determining the suitability of a donor or a unit. Clinical Laboratory - requires registration, but no real activity from the FDA on this area. Radiation dosage calculators - falls under the 'accessory' category. Several doctors have been subject to actions because the distributed a calculation program they had written. Also, if you wish to submit any data to the agency electronically, submit data that is produced from electronically collected or stored data, or maintain FDA required record electronically, those systems must comply with 21 CFR part 11. The FDA represents that it is watching the development of 'expert' systems in healthcare, and if they ever get enough funding to pursue it, I think we'll see a lot of activity from them in that area. Lack of funding is (in my opinion) the main reason that they have been relatively inactive in clinical laboratory systems. The good news is that the FDA has become somewhat more reasonable and easy to deal with since FDAMA (FDA Modernization Act) that required them to put timetables on submission approvals/rejections and generally be a more responsive agency. Several new 510K submission and update procedures have been implemented that streamline the process, particularly for updates to existing devices. Mark
----- Original Message ----- From: "Furnari, Chris" <[EMAIL PROTECTED]> To: <[EMAIL PROTECTED]> Sent: Friday, October 19, 2001 1:17 PM Subject: RE: Why has Palm caught on Over Open source > the only group of software packages that is regulated by the FDA is Blood > Bank software at least from what I recall.. Lab software may be regulated as > well.... > > Chris Furnari > Programmer/Systems Integration > Information Systems Division > Westchester Medical Center, Valhalla, NY > Phone: 914.493.7049 Fax: 914.493.1698 > > > > -----Original Message----- > > From: Wayne Brandes [SMTP:[EMAIL PROTECTED]] > > Sent: Friday, October 19, 2001 1:56 PM > > To: [EMAIL PROTECTED] > > 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 > >
