Originally Published IVD Technology January 2002
INDUSTRY NEWS
FDA to withdraw proposed waived-status criteria
FDA is planning
to rescind its draft guidance of alternative criteria for obtaining waived-complexity
status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
FDA officials say that the agency decided to withdraw its "Guidance for
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver;
Draft Guidance for Industry and FDA" after receiving notice that the Centers
for Medicare and Medicaid Services (CMS; Baltimore) actually have authority
over the waiver criteria for CLIA. As a result, the waiver criteria will for
now defer to the guidelines that were in the original proposed rule of September
13, 1995.
"CMS maintains
the authority for CLIA. That’s pretty much what FDA has been told,"
says Clara Sliva, acting CLIA coordinator at FDA’s Center for Devices and
Radiological Health. "CMS put out the proposed rule, so they’re also
going to put out the final rule. But it should be emphasized that all of the
CLIA categorizations still come through FDA, and we’re really the people
that companies should talk to. The only thing that has changed is the criteria
that we’re following."
The decision will
not prevent FDA from being involved in developing new criteria for waived-complexity
status. While CMS has final authority on all matters relating to CLIA, it will
be working in conjunction with FDA as well as the Centers for Disease Control
and Prevention (CDC; Atlanta) to formulate and update the waiver criteria guidelines,
according to FDA officials.
"We’re
working with CMS and CDC right now on the final rule for waiver and to clarify
the criteria for waiver," says Sliva.
When it was first
released, FDA’s draft guidance on waiver criteria stirred up a fair amount
of controversy in the IVD community. One of the biggest points of contention
was the agency’s definition of the accuracy of tests. Under the proposed
guidelines, FDA interpreted the term accurate to be a measure of test performance;
specifically, that a test would perform the same in the hands of untrained users
as it would in the hands of laboratory professionals when using the device under
realistic conditions.
Various professional
associations, such as the American Association for Clinical Chemistry (AACC;
Washington, DC), took issue with this definition of accuracy, saying that the
accuracy of tests should be demonstrated "by comparing the test to a generally
accepted or approved method and/or by analyzing well-characterized reference
materials."
"We believe
[FDA’s definition] is an inappropriate use of the term accurate as understood
by the vast majority of caregivers, policymakers, and the public," wrote
Larry Kricka, then AACC president, in a letter to FDA. "Using this definition
may needlessly confuse caregivers about the correctness of the result. What
FDA is describing under this section is performance comparability, not accuracy."
FDA officials clarified
that such differences did not contribute to the agency’s decision to rescind
its draft guidance.
"The withdrawal
had nothing to do with the contents of our guidance," says Sliva. "No
one said to us that FDA’s interpretation is wrong, and CMS’s interpretation
is right. That wasn’t the issue. The issue was simply that CMS has the
authority for CLIA."
While some industry
groups are pleased by FDA’s decision to withdraw its proposed waiver guidelines,
other groups have expressed concern about the possible negative effects that
this decision will have on IVD companies.
"For manufacturers,
it means that we must go back to the 1995 criteria," says Carolyn Jones,
associate vice president for regulatory and technology affairs at AdvaMed (Washington,
DC). "Although the 1995 criteria have been used to grant waiver, the application
of the criteria can limit the number of products eligible for waiver. Examples
of this can be seen when CDC just didn’t want to see a particular test
in waived labs."
Richard Park
Copyright ©2002 IVD Technology
