Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved the FDA’s “Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff”. Like most guidance documents reviewed by OIRA prior to release, this document was not listed in the latest Unified Agenda.
There is an interesting article here
on the purpose and use of ‘computer software assurance’ processes in the
medical device sector.
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