FDA Updates 2008 Guidance on Categories of Lab Testing

The Food and Drug Administration (FDA) released March 12 an updated guidance on categorization of laboratory tests. The document, “Administrative Procedures for CLIA Categorization: Guidance for Industry and Food and Drug Administration Staff,” replaces a document issued in May 2008. CLIA refers to the Clinical Laboratory Improvement Amendments of 1988. The FDA noted that the CLIA law requires that clinical laboratories obtain a certificate before accepting materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or the impairment of or assessment of the health of human beings. “The type of CLIA certificate a laboratory obtains depends upon the complexity of the tests it performs,” the FDA said, adding that CLIA regulations describe three levels of test complexity: waived tests, moderate-complexity tests, and high-complexity tests. Categorization, Waivers The new guidance covers procedures for determining CLIA categorization, as well as CLIA waiver protocols and applications. In the first area, the agency said that categorization of in vitro diagnostic tests is determined “at the time of review of a premarket notification submission (510(k)) or a premarket approval application (PMA) under the Federal Food, Drug, and Cosmetic Act.” In those cases when a 510(k) or PMA isn’t needed but CLIA categorization still is appropriate (the agency gave as an example the devices exempt from premarket notification), manufacturers should submit a request for CLIA categorization, including a copy of the test package insert with test instructions, to the Center for Devices and Radiological Health Document Control Center. And to expedite review, the FDA “strongly encourages” submission of an eCopy. In the second area, involving waivers, the guidance said that a test initially categorized as moderately complex might meet the statutory criteria for a CLIA waiver “if the device is simple to use and the sponsor demonstrates in studies conducted at the intended use sites that the test is accurate and poses an insignificant risk of erroneous results.” The agency guidance said that if a company whose test is categorized as moderate complexity believes the test meets the statutory criteria for CLIA waiver, it may submit a CLIA “waiver by application” to request categorization of the test system as waived. The agency said that under the medical device user fees law known as MDUFA, from fiscal years 2013 through 2017 the agency made commitments for review times of CLIA waiver by applications. For a substantive interaction, which may be a request for additional information (via letter or e-mail), the review time (measured in FDA days) is 90 days. For a final decision on the waiver, the times under the user fees law are 180 days (with no panel), 330 days (with a panel), and 210 days for a dual 510(k) and CLIA waiver by application. The new guidance also directs readers to a January 2008 FDA guidance, “Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” That guidance is available at www.fda.gov/MedicalDevicesDeviceRegulationandGuidance/GuidanceDocuments/ucm079632.htm. The text of the new guidance document is at www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070889.pdf. Takeaway: FDA’s updated guidance on categorization of laboratory tests should not have a major impact on clinical laboratories.