WASHINGTON, Sept. 24 -- Food and Drug Administration has issued a notice called: Computer Software Assurance for Production and Quality System Software; Guidance for Industry and Food and Drug Administration Staff; Availability.
The notice was published in the Federal Register on Sept. 24 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Computer Software Assurance for Production and Quality System Software." FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device prod...