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...Read More

Allergy Laboratories 8/14/98 4. Failure to routinely calibrate, inspect, or check for accuracy and to exercise appropriate controls for automatic, mechanical, or electronic equipment or other types of equipment, including computers, used in the manufacture, processing, packaging, and holding of a drug product according to a written program designed so as to assure performance [21...Read More