On June 27, 2016, FDA published the Quality Metrics Technical Conformance Guide – Technical Specifications Document Version 1.0 (Guide).  This guide serves as the technical reference for implementation of the draft FDA guidance for industry on Request for Quality Metrics.  The purpose of the draft guide is to provide technical recommendations for the submission of quality metric data.  It is intended to ensure clear expectations for industry on the submission of quality metric data as described in the Request for Quality Metrics draft guidance.

The guide discusses the file format for the data submissions, including special characters, labels and symbols.  It also outlines each data element that is to be provided to FDA and also includes tables for mandatory and optional data element formats with a description of each.

This guide supplements the draft FDA guidance for industry on Request for Quality Metrics and provides recommendations about submission of information that will support the FDA’s calculation of quality metrics.

Comments on the guide can be submitted to FDA through September 26, 2016.

Click here to read the Rx-360 Summary on the draft Guidance.