Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based in Vitro Diangostics

The ICR collects information from administrators of public human genetic variant databases who apply for recognition of their database to support clinical validity for genetic and genomic-based in vitro diagnostics. The information collected will be used by FDA to ensure the process by which administrators of genetic variant databases could voluntarily apply to FDA for recognition, and how FDA would review such applications and periodically reevaluate recognized databases. FDA believes that if administrators of genetic variant databases follow the recommendations, including transparency regarding evidence evaluation, and obtain FDA recognition as described, the data and assertions within would generally constitute valid scientific evidence that can be used to support clinical validity.

The latest form for Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based in Vitro Diangostics expires 2021-03-31 and can be found here.