CLIA Waiver Decisions: FDA Begins Posting Summaries

Regulatory NewsRegulatory News | 03 October 2017 |  By 

The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part of a pilot to boost transparency.

FDA also updated its guidance on its administrative procedures for CLIA categorization for IVDs to reflect new commitments under the recently reauthorized Medical Device User Fee Amendments (MDUFA IV).

So far, the agency has posted decision summaries for two tests, both of which met FDA's criteria for CLIA Waiver approval, developed by Quidel Corporation, to detect influenza and respiratory syncytial virus (RSV) using the company's Sofia and Sofia 2 analyzers.

FDA says it believes releasing the decision summaries will help the public understand its waiver application decisions and allow IVD makers to see what types of studies were done to support past CLIA waiver approvals.


Under CLIA, FDA categorizes IVDs as either moderate or high complexity or "waived."

In order to perform moderate and high risk tests, clinical laboratories are required to have a CLIA certificate, meet certain quality standards and agree to routine inspections, while labs that only perform waived tests only need a CLIA certificate.

IVDs cleared for home or over-the-counter use are automatically waived, and IVD makers can request that moderate complexity tests be waived through FDA's CLIA waiver by application process.

FDA makes its categorization decision while reviewing an IVD's premarket submission (either a 510(k) or premarket approval (PMA) application) and typically notifies sponsors of their IVD's complexity category within two weeks of a positive clearance or approval decision.

Afterwards, sponsors of moderate risk IVDs can submit a CLIA waiver by application to FDA if they believe their test meets the waiver criteria.

Alternatively, sponsors can submit a dual 510(k) and CLIA waiver by application in the same submission, though FDA asks that sponsors wishing to do so notify the agency during the pre-submission process.

In order for a moderate risk IVD to qualify for a CLIA waiver by application, an IVD maker must demonstrate that the test is simple to use and poses an "insignificant risk of an erroneous result" through flex and clinical studies.

MDUFA IV Commitments

FDA's updated guidance on CLIA categorization details the agency's procedures for assigning a CLIA complexity category and the agency's new CLIA waiver by application commitments.

Under MDUFA IV, FDA agreed to have a substantive interaction with sponsors within 90 days on 90% of CLIA waiver applications; reach a MDUFA decision on 90% of CLIA waiver applications in 150 days, or 320 days if an advisory panel is necessary; and review 90% of dual 510(k) and CLIA waiver applications within 180 days.

While the timelines are slightly sped up, FDA has a bit more leeway on the number of applications it needs to review on time at 90% across the board, whereas under MDUFA III, FDA committed to having a substantive interaction in 90 days and reaching a MDUFA decision in 180 days, or 330 days with an advisory panel for 95% of applications.

FDA also agreed to provide written feedback to applicants if it fails to reach a decision on a CLIA waiver by application submission within 20 days of its goal date detailing any outstanding issues keeping the agency from reaching a decision.

Decision Summaries, Guidance


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