Regulatory Focus™ > News Articles > New FDA Guidance Explains the Ins and Outs of the CLIA Categorization Process for IVDs

New FDA Guidance Explains the Ins and Outs of the CLIA Categorization Process for IVDs

Posted 12 March 2014 | By Alexander Gaffney, RAC

A new final guidance document released by US medical device regulators makes recommendations on how to comply with the Clinical Laboratory Improvements Amendments (CLIA), a 1988 law that instituted laboratory testing requirements meant to improve in vitro diagnostic testing.

The guidance, Administrative Procedures for CLIA Categorization, was released by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on 11 March 2014. The guidance supersedes an earlier May 2008 guidance of the same name.


Under CLIA, FDA is responsible for categorizing clinical laboratory devices that are used with human tissue samples. Those clinical laboratory devices are specifically those that are under premarket review with CDRH or other FDA centers, are exempt from the 510(k) premarket notification process, or are seeking a waiver categorization from FDA as having negligible risks.

The regulations established under CLIA established three device classification categories: waived tests (low complexity), moderate complexity tests, and high complexity tests.

The general idea is that while IVDs and other laboratory-developed tests (LDTs) may not be as dangerous to consumers as devices which work directly upon a patient (like a pacemaker), the information obtained from such devices is used by patients and healthcare providers to make important decisions. If those tests are created or administered under deficient conditions, it could lead to an inaccurate result.

Low-risk devices may be used at most doctors' offices, while moderate- and higher-risk devices are restricted to facilities appropriately accredited under CLIA.

New Guidance

So what does all this have to do with FDA's new guidance? Simple: The guidance goes into how companies should submit devices to FDA to categorize the complexity of the product.

"In cases where a 510(k) or PMA (Premarket Application) is not needed but CLIA categorization is still appropriate (e.g., devices exempt from premarket notification), manufacturers should submit a request for CLIA categorization," FDA explains in the guidance. Such an application should be included with both a copy of the package insert and instructions.

Categorization decisions are generally made within 30 days of the initial request.

For unapproved devices under premarket review at FDA, the agency will create a CLIA Record (CR) number for each received device. Regulators will then assess the complexity of each device in accordance with its package insert and instructions using criteria under 42 CFR 493.17 and 493.15.

Subsequent changes to the device (name, distributor, manufacturer) should be submitted to FDA with reference to the original CR number, FDA added.

The guidance also explains the waiver process, noting that only devices which are approved under a PMA or cleared via the 510(k) pathway are eligible for waivers. CLIA waivers take anywhere between 90 to 330 days for FDA to process, depending on the complexity of the device. Devices seeking a waiver should be low-complexity devices, though some moderate-complexity devices may qualify as well.


Administrative Procedures for CLIA Categorization

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