Guidance for Off-the-Shelf Software Use in Medical Devices

Guidance for Off-the-Shelf Software Use in Medical Devices

[Robert C. Leif, Ph.D.]

To: Comp.Lang.Ada and other interested parties.

From: Bob Leif, Ph.D.
Vice President Ada_Med, a Division of Newport Instruments

The cancellation of the Ada mandate and the shift by DoD to Off-the-Shelf
Software has and still is a controversial subject.  I wish to call your
attention to the work of a Government agency that has had considerable
experience with the use of commercial software for critical applications,
the Food and Drug Administration.  The Draft Guidance for Off-the-Shelf
Software Use in Medical Devices produced by the Office of Device
Evaluation, CDRH, 9200, Corporate Boulevard, HFZ-450, Rockville, MD 20850
(http://www.fda.gov/cdrh/ode/otssguid.pdf) is an excellent document.

The Department of Defense has excellent software technology that could be
used for medical devices.  I believe that Senator Harkness once and maybe
still has forced the Department of Defense to use some of its funds for
cancer research.  A very good use of these funds would be for Defense to
share its software technology with the health related departments, such as
NIH and FDA, and in turn to benefit from their knowledge and experience.