The Food and Drug Administration (FDA) is seeking public comments on a proposal to gather information related to the use of public human genetic variant databases. These databases are used to support the clinical validity of genetic and genomic-based tests. The FDA is considering extending their guidelines and processes for recognizing these databases as trustworthy sources of scientific evidence. The deadline for submitting comments is March 26, 2021, and interested parties can access the collection of information online and share their feedback.
Simple Explanation
The FDA wants to hear what people think about using special databases that help check if medical tests work well. They want to make sure these databases are good and safe, and need people's ideas on their plan.