From mboxrd@z Thu Jan 1 00:00:00 1970 X-Spam-Checker-Version: SpamAssassin 3.4.4 (2020-01-24) on polar.synack.me X-Spam-Level: * X-Spam-Status: No, score=1.4 required=5.0 tests=BAYES_50,INVALID_MSGID autolearn=no autolearn_force=no version=3.4.4 X-Google-Language: ENGLISH,ASCII-7-bit X-Google-Thread: 103376,5a8fd130f8645ee9,start X-Google-Attributes: gid103376,public From: "Robert C. Leif, Ph.D." Subject: Guidance for Off-the-Shelf Software Use in Medical Devices Date: 1997/07/16 Message-ID: <3.0.32.19970716080042.006eae80@mail.4dcomm.com>#1/1 X-Deja-AN: 257345967 Sender: Ada programming language X-Sender: rleif@mail.4dcomm.com Comments: cc: "Hamilton, J. LTC EECS" , mailserv@acm.org, Linda.Brown@osd.pentagon.mil, Dan Spyker Newsgroups: comp.lang.ada Date: 1997-07-16T00:00:00+00:00 List-Id: 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 The Draft Guidance for Off-the-Shelf Software Use in Medical Devices produced by the Office of Device Evaluation, CDRH, 9200, Corporate Boulevard, HFZ-450, Rockville, MD 20850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.