In the June 27, 2016, Federal Register, FDA announced the availability of a technical specifications document titled "Quality Metrics Technical Conformance Guide, Version 1.0." The document provides technical recommendations for submitting quality metric data. It also supplements and serves as the technical reference for implementing the FDA's draft guidance for industry titled ''Request for Quality Metrics'' (published July 28, 2015). Comments are due September 26, 2016.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.