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Quality Metrics Technical Conformance Guide-Technical Specifications Document; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a Technical Specifications Document entitled ``Quality Metrics Technical Conformance Guide, Ve...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a Technical Specifications Document entitled ``Quality Metrics Technical Conformance Guide, Version 1.0.'' This Guide provides technical recommendations for the submission of quality metric data. It serves as the technical reference for implementation of the draft FDA guidance for industry, when finalized, on ``Request for Quality Metrics,'' dated July 28, 2015.

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81 FR 41545

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“Quality Metrics Technical Conformance Guide-Technical Specifications Document; Availability,” thefederalregister.org (June 27, 2016), https://thefederalregister.org/documents/2016-15099/quality-metrics-technical-conformance-guide-technical-specifications-document-availability.