In Vitro Diagnostics
This article was originally published in SRA
Executive Summary
US FDA releases guidance on allowing waivers under CLIA
US FDA releases guidance on allowing waivers under CLIA
The US Food and Drug Administration has revised its recommended approach on how manufacturers of simple and low-risk in vitro diagnostic devices can demonstrate that their products are eligible for a waiver under the Clinical Laboratory Improvement Amendments Act1,2.
Under the CLIA, all clinical laboratories are required to obtain a certificate from the secretary of the Department of Health and Human Services before accepting materials derived from the human body for testing. Labs that perform only tests that are simple and have an “insignificant risk of an erroneous result” may obtain a certificate of waiver.
The FDA has the authority to ascertain the risk-factor of tests, and the advice contained in a recently finalised guidance entitled Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices is intended to guide manufacturers on what data they need to provide in support of their waiver application. The recommendations are based on the agency's interpretation of the law, its experience with CLIA complexity determinations and comments from stakeholders on the draft version issued in 2005.
The guidance allows for additional supplementation of actual patient specimens in the clinical study with alternative samples, preferably banked patient samples. In cases where neither patient specimens nor banked samples are available, studies may be supplemented with other types of prepared samples, for example spiked or diluted samples that mimic patient samples in terms of analyte and matrix.
The guidance specifies that up to a total of one third of the clinical study samples may be supplemented with these types of alternative samples. It provides more flexibility in selecting the comparator method as well as more consistency in terms of the criteria for accuracy for waived tests as compared with moderate and high complexity tests.
The FDA clarifies that the guidance only represents the agency's current thinking on reporting results from studies evaluating diagnostic tests. Companies may use an alternative approach for a waiver application as long as it satisfies the CLIA statutory requirements.
References
1. Federal Register, 30 January 2008, 73(20), 5574-5575, www.fda.gov/OHRMS/DOCKETS/98fr/E8-1557.pdf
2. FDA guidance on Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices, 30 January 2008, www.fda.gov/cdrh/oivd/guidance/1171.html#3
References
1. RAJ Devices Online, 23 January 2008
2. The Regulatory Affairs Journal - Devices, 2008, 16(1), 29-30