FDA expands scope of genetic testing regulations
This article was originally published in Clinica
Executive Summary
The US FDA is preparing a notice of proposed rulemaking that would expand the its oversight of genetic testing. The notice, which is still "being worked on and resolved", would require the premarket review of some of the reagents used for genetic testing, explained Steven Gutman, director of the office of in vitro diagnostic device evaluation and research within the device centre (CDRH).