Brian,

Most definitely yes, see http://www.fda.gov/cdrh/emc/

The FDA is concerned with the correct operation of medical equipment, so
immunity requirements are also included.

Regards,

Jon Griver
www.601help.com
The Medical Device Developer's Guide to IEC 60601-1

>
> Do FDA specify their own EMC requirements/standards or do they use those
of
> the FCC (Part 15?) ?
>
> Brian
>
>
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