FDA Issues Quality Metrics Technical Conformance Guide

On July 28, 2015, the FDA published a draft guidance, entitled “Request for Quality Metrics.”  The draft guidance “outlines FDA’s authority to require owners and operators of such establishments to provide upon request records and information that FDA may inspect under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  The FDA states that the guide supplements the draft guidance and is thus incorporated into the draft guidance by reference.

Formatting Recommendations

In the document, FDA provides a number of recommendations regarding the submission of quality metric data.  Some of the information provided, includes:

• Although the Agency currently receives, processes, and archives electronic files in a number of formats, it recommends that Extensible Markup Language (XML) format is used when submitting data related to quality metrics.
• The guide states that the “length of variable names, descriptive labels, and dataset labels should not exceed the maximum permissible number of characters,” which is provided as follows:
  • Variable name: eight characters max.
  • Variable descriptive label: 40 characters max.
  • Dataset label: 40 characters max.
• Variable names, and variable and dataset labels should include only American Standard Code for Information Interchange (ASCII) text codes.
• Punctuation, dashes, spaces, or other non-alphanumeric symbols should not be included in variable and dataset names.
• Punctuation can be used in variable and dataset labels. However, the Agency notes that special characters, such as the following, should not be used:
  • Unbalanced apostrophe, e.g., Parkinson's.
  • Unbalanced single and double quotation marks.
  • Unbalanced parentheses, braces, or brackets, e.g., ‘(‘, ‘{‘and ‘[‘.
  • ‘<’ less than sign and ‘>’ greater than sign.

Contents of a Submission

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:

1. Data elements specifications
2. Data elements – descriptions
3. Mandatory data elements – formats
4. Optional data elements – descriptions

For additional details on the Agency’s content recommendations, view the FDA’s full guide.

Data Validation Rules

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.”

Are you in the process of submitting quality metrics or other data to the Agency? We can help you achieve a successful outcome with FDA.  To learn more about our services and how we can help you, contact us today.