Where the line runs between a laboratory-developed test and an IVD
How 42 CFR Part 493 and the in vitro diagnostic definition in 21 CFR Part 809 treat a test that a laboratory develops, modifies and runs itself.
Tag: laboratory-developed-tests
2 posts
What CLIA requires of a laboratory before it reports a result
How CLIA certification, performance specification validation and personnel qualifications apply to a laboratory before it reports a patient test result.