Stamps in medical devices

Archiver

Has anyone used Basic Stamps idevices requiring FDA software
verification?

Thanks
Art Atkinson

Archiver

As far as you know, does the FDA test/license medical device sub-systems
(like an embedded BS) or a full system (e.g. a CAT scanner, or ECG machine)
regardless of the sub-systems it may contain?

At 07:36 PM 4/20/00 +0000, you wrote:
>Has anyone used Basic Stamps idevices requiring FDA software
>verification?
>
>Thanks
>Art Atkinson
>
>
>
>

Archiver

I'm not an expert, but I suspect this depends on several factors: 1) proximity
of Stamp power and signal to patient, and use of appropriate electrical
isolation of both; 2) any control features of Stamps as critical to patient
safety; 3) "class" of the device I-III, with III being most invasive.
Dennis
Larry Pfeffer wrote:

> As far as you know, does the FDA test/license medical device sub-systems
> (like an embedded BS) or a full system (e.g. a CAT scanner, or ECG machine)
> regardless of the sub-systems it may contain?
>
> At 07:36 PM 4/20/00 +0000, you wrote:
> >Has anyone used Basic Stamps idevices requiring FDA software
> >verification?
> >
> >Thanks
> >Art Atkinson