You are here: Home > News > Computer Software Assurance for Production and Quality System Software
Computer Software Assurance for Production and Quality System Software
On 13 September 2022 the FDA published draft guidance on computer software assurance for industry and FDA staff. Submit comments by 14 November 2022.
FDA is issuing this draft guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.
