FDA Releases Guidances on Dual 510(k)–CLIA Waiver Submissions, Test Accuracy

The FDA issued two draft guidances to encourage using the 510(k)-Clinical Laboratory Improvement Amendments (CLIA) waiver dual application pathway for new in vitro diagnostic devices, and to update its policies for demonstrating accuracy to obtain a CLIA designation.

Under current regulations, clinical laboratories must obtain CLIA waiver certificates to perform tests that are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result,” and these include those that “employ methodologies that are so simple and accurate” that a user’s erroneous results can be rendered “negligible,” the agency said.

The process industry historically followed was to obtain a clearance or approval of an IVD test designed for CLIA-waived settings, and to then apply for a CLIA certificate.

The optional dual submission pathway — created by MDUFA III in 2012 — is in “many instances the least burdensome and fastest approach” as it allows sponsors to simultaneously meet the requirements for both 510(k)s and CLIA designations, the FDA said, adding that it is especially appropriate for simple devices subject to premarket notification requirements with fail-safe and failure alert mechanisms, and requiring only a few pre-analytical steps.

The new draft guidance outlines recommendations on what to include in a dual submission, such as a device description that demonstrates simplicity, and on designing comparison and reproducibility studies in support of the submission. An industry commitment, established earlier this year as part of MDUFA IV, requires applicants to inform the FDA of their intent for a dual submission.

But the expectation is for the use of this pathway to reduce the FDA’s overall review time for the submissions. For IVD manufacturers, the agency hopes the guidance will also help reduce study-related costs and save them time during the submission process.

“FDA believes increased use of this pathway will speed up the process of bringing simple and accurate IVD devices to CLIA-waived settings, which will better serve patients and providers,” the agency said.

Accuracy is a key element for granting a CLIA waiver, according to the FDA. In a separate draft guidance document, the agency proposed to revise its CLIA Waiver Guidance from Jan. 30, 2008, as required by the 21st Century Cures Act of 2016.

The FDA said that, when finalized, changes to the 2008 guidance will provide “additional details and pathways for demonstrating that a test has an insignificant risk of erroneous result[s].”

Read the Recommendations for Dual 510(k) and CLIA Waiver by Application Studies draft guidance here: www.fdanews.com/11-30-17-510kCLIAWaiver.pdf.

Read the Select Updates for Recommendations for CLIA Waiver Applications for Manufacturers In Vitro Diagnostic Devices draft guidance here: www.fdanews.com/11-30-17-CLIAWaiver.pdf.