The purpose of this guidance is to provide FDA expectations for and recommendations on use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated medical products conducted in the United States and abroad. Using standard terminology for age, sex, gender, race, and ethnicity helps ensure that subpopulation data is collected consistently. The recommended standardized approach is based on the Office of Management and Budget (OMB) Directive 15 and developed in accordance with section 4302 of the Affordable Care Act, the HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status, and the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan. This guidance lists the OMB categories for race and ethnicity and describes FDA’s reasons for recommending the use of these categories in medical product (drugs, biologics, and devices) applications. In addition, this guidance recommends a format for collection of race and ethnicity clinical trial data that are submitted in standardized data sets per the Study Data Tabulation Model, in the electronic Common Technical Document (eCTD), and as specified in FDA’s Guidance on providing regulatory submissions in electronic format.
This document is intended to provide guidance on:
- Meeting the requirements set forth in the 1998 final rule regarding presentation of demographic data on investigational new drug (IND) applications and new drug applications (NDAs) (known as the “Demographic Rule”) and collection of race and ethnicity data in biologics license applications (BLAs) and medical device applications
- Addressing the FDA Safety and Innovation Act, Section 907 Action Plan to improve demographic subgroup gaps in data quality