The Clinical Laboratory Improvement
Amendments of 1988 (CLIA) law specified
that laboratory requirements be based on
the complexity of the test performed and
established provisions for categorizing
a test as waived. Tests may be waived
from regulatory oversight if they meet
certain requirements established by the
statute. The section of the statute
specifying the criteria for categorizing
a test as waived was excerpted without
elaboration in the regulations at 42 CFR
493.15(b) and 493.15(c) contained
a list of these waived tests as they may
be described by FDA guidelines.
See More Info on test Waived by FDA CLIA
Guidelines Here.
Alco-Screen 02
