Review and Update of Device Establishment Inspection Processes and Standards; Extension of Comment Period

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The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register on March 29, 2019. FDA requested comments on the draft guidance for industry entitled "Review and Update of Device Establishment Inspection Processes and Standards." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.