Food and Drug Administration Quality Metrics Reporting Program; Establishment of a Public Docket; Request for Comments

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on changes to FDA's previously proposed quality metrics reporting program (QM Reporting Program). This notice describes considerations for refining the QM Reporting Program based on lessons learned from two pilot programs with industry that were announced in the Federal Register in June 2018, a Site Visit Program and a Quality Metrics Feedback Program, as well as stakeholder feedback on FDA's 2016 revised draft guidance for industry entitled "Submission of Quality Metrics Data." FDA is interested in responses to the questions listed in section III of this document, in addition to any general comments on the proposed direction for the program. This notice is not intended to communicate our regulatory expectations for reporting quality metrics data to FDA but is instead intended to seek input from industry to inform the future regulatory approach.