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The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.
On June 24, 2016, FDA released the draft Quality Metrics Technical Conformance Guide, which supplements FDA’s draft guidance, Request for Quality Metrics. The guide discusses the submission of quality metric data. Specifically, the guide addresses the format of electronic submissions, data element specifications, mandatory data elements, and optional data elements.
The guide also details data validation rules. Data validation is defined in the guide as “a process that attempts to ensure that submitted data are both compliant and useful.” FDA states in the guide that “data validation is one method used to assess submission data quality â¦ The data validation process can identify data issues early in the review that may adversely affect the use of the data.” FDA states that companies should validate their metric data before submission using the validation rules, which will be posted on the FDA website once the quality metrics guidance is finalized, and correct any validation errors.