FDA CDRH Office of Device Evaluation standards recognition statement for ” IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements For safety; 4. Collateral Standard: Programmable electrical medical systems”. FDA did not choose to recognize this standard for software submissions or even outright for risk management. They did issue a recognition statement explaining their...
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FDA CDRH Office of Device Evaluation’s “Draft Guidance for Implantable Cardioverter-Defibrillators Version 4.2” June 19, 1994. Section II.B addresses this so for documentation requirements for 510(k) submissions for this type of medical device by simply referring to the general software submission guidance and the Off-the-shelf software Submission guidance. Earlier versions of this draft at additional...
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“Information Technology – Software Lifecycle Processes” and issued August 1995. This document was the basis for development of the AAMI Medical Device Software Development Standard and was one of the first software standards recognized by FDA for submission purposes. It can be ordered directly from the IEC at www.iec.ch. Just go to their web store...
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