Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff

Issue Date: September 12, 2017
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, Clinical – Medical, Good Clinical Practice (GCP), Labeling, Pediatric Product Development, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Physical Medicine, Orthopedic, Ophthalmic, Obstetrical & Gynecological, Neurological, Molecular and Clinical Genetics, Immunology & Microbiology , Cardiovascular , Hematology & Pathology , General Hospital & Personal Use , General & Plastic Surgery , Gastroenterology-Urology , Ear, Nose & Throat , Dental , Clinical Chemistry & Clinical Toxicology , Radiology, Radiological Health
Status: Final

Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff

The purpose of this guidance is to outline the FDA’s expectations and provide recommendations for the evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and ethnic groups. Proper evaluation and reporting of this data can benefit patients, clinicians, researchers, regulators, and others. Additionally, it is important that clinical trials include diverse populations that reflect the intended use population. In general, to achieve an unbiased estimate of treatment effect in the general population, sponsors should develop a strategy to enroll diverse populations including representative proportions of relevant age, racial, and ethnic subgroups, which are consistent with the intended use population of the device. This guidance includes recommendations and considerations to assist sponsors in developing such a strategy. FDA recognizes the practical challenges in achieving the appropriate enrollment of diverse populations. This guidance includes recommendations to overcome barriers to enrollment in order to balance these recommendations with least burdensome principles.

Download the Guidance Document