On July 28, 2015, the FDA published a draft guidance, entitled “Request for Quality Metrics.” The draft guidance “outlines FDA’s authority to require owners and operators of such establishments to provide upon request records and information that FDA may inspect under section 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act, or the Act), and describes an initial set of requests the Agency intends to make to certain owners and operators.”
On June 24, 2016, the Agency issued a document entitled “Quality Metrics Technical Conformance Guide,” which is intended to clarify the Agency’s expectations for the submission of data concerning quality metrics. FDA notes that the guide “serves as the technical reference for implementation of the draft FDA guidance for industry on Request for Quality Metrics.” In addition, the guide provides recommendations regarding the submission of information to support the Agency’s calculation of quality metrics. The FDA states that the guide supplements the draft guidance and is thus incorporated into the draft guidance by reference.
In the document, FDA provides a number of recommendations regarding the submission of quality metric data. Some of the information provided, includes:
The guide includes a number of recommendations related to the content and format of a submission. The various recommendations touch on a number of topics, including:
For additional details on the Agency’s content recommendations, view the FDA’s full guide.
According to the conformance guide, “data validation is a process that attempts to ensure that submitted data are both compliant and useful.” FDA states that its validation rules will be included in the final Request for Quality Metrics guidance, and will be posted on the external FDA Web Page at that time. Furthermore, FDA notes that “establishments should validate their metric data before submission using the posted validation rules and correct any validation errors.”
August 28, 2015
Last month, FDA published a draft guidance titled “Request for Quality Metrics,” which outlined the ways in which it intends to collect and use quality metrics. The guidance states that the data will...
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