The FDA has released its draft guidance for industry and staff concerning recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) as it relates to those tests that will be eligible for a CLIA waiver.
The current definition of a test receiving a CLIA waiver is as follows: “simple laboratory examinations and procedures that have been approved by the FDA for home use or that .... are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”
Although the Centers for Medicare & Medicaid Services (CMS; Baltimore) and Centers for Disease Control and Prevention (CDC; Atlanta) also administer CLIA, it is the FDA’s role to determine which of three categories tests will fall under: waived, moderate complexity or high complexity (Diagnostics & Imaging Week, June 16, 2005).
Vincent Stine, PhD, director of government affairs for the American Association for Clinical Chemistry (AACC; Washington), said that the AACC is still studying the FDA’s language in the proposed guidance and will provide comment on the document in the coming weeks.
In the meantime, there is a public comment period.
The FDA said that in developing the recommendations it took into consideration comments from the Clinical Laboratory Improvement Advisory Committee (CLIAC) which, as its name suggests, plays an advisory role for CLIA regulations to the agencies that administer it.
The FDA said that it also considered input from an open public workshop in August 2000, as well as a proposal presented by the Advanced Medical Technology Association (Washington) at the September 2003 CLIAC meeting, plus proposed recommendations by CLIAC from a meeting that body held in February 2004.
Earlier this year following an AACC audioconference on the subject, Steve Gutman, MD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, wrote Diagnostics & Imaging Week in an e-mail that “AdvaMed fielded this proposal because the organization felt that the rules being applied to waiver decisions were not as refined as they could be and failed to account for a number of cutting-edge IVD constructs including traceability in methods and risk management.
The proposed guidelines were published in the Federal Register last week.
Above the introduction to the document, the FDA wrote that “This draft guidance, when finalized, will represent the Food and Drug Administration’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.”