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The U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) regulation (21 CFR Part 812) oversees clinical research involving “investigational” medical devices. FDA considers next-generation sequencing (NGS) and other genomic tests to be in vitro diagnostic devices (IVDs), a type of medical device. As genomic technologies continue to enter the clinical realm, IDE regulation has become increasingly relevant. Sometimes, the applicability of IDE regulation to genomic tests can be difficult to interpret because the regulation was originally crafted to oversee traditional medical devices (e.g., heart valve or insulin pump).

As a leader in genomic research, NHGRI has created the IDE Greenhouse as an educational resource to help understand the regulation in the context of genomics. Genomic studies that were either successfully granted IDEs or classified as posing non-significant risk (NSR) provided the following documents as a reference for investigators and stakeholders. Three studies from the NHGRI Newborn Sequencing in Genomic Medicine and Public Health (NSIGHT) program along with the NIH All of Us research program shared their IDE documents. NHGRI thanks the contributing investigators for their willingness to share this work with the broader research community.

Researchers interested in contributing additional documents to this resource can reach out to ppab@nih.gov.


These documents are examples and should not be construed as templates for preparing an IDE application. There are several approaches to develop a successful IDE application. FDA formats or rules may have changed since these applications were prepared; therefore, applicants should always follow FDA guidance and requirements. Content should be used for nonprofit educational purposes only.

NSIGHT NC Nexus (University of North Carolina, Initiated 2014)

All of Us (National Institutes of Health, Initiated 2020)

Original IDE Application

Note: All of Us study documents are provided in a single file. NHGRI created the table as a tool to quickly navigate to specific content.

Last updated: February 2, 2022