…ot enforced requirements related to registration and listing, reporting adverse events to FDA, current good manufacturing practices (CGMPs), or premarket review of an IVD by FDA prior to use of the LDT in patient care, among other requirements. The rationale for this approach was…

…ols, including premarket notification, reporting requirements regarding adverse events and corrections and removals, IDE requirements (though most investigations of IVDs are exempt from most provisions of the IDE regulation), and other applicable requirements under the FD&C Act a…