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FDA Updates Draft Guidance for Dual CLIA Waiver, 501(k) Process

NEW YORK (360Dx) 

– The US Food and Drug Administration this week updated its draft guidance for the dual 510(k) clearance and CLIA waiver process.

The dual 510(k) and CLIA waiver application pathway, first established as part of the Medical Device User Fee Amendment of 2012, allows users to shorten the steps to getting 510(k) and CLIA waiver approval by conducting a single set of comparison and reproducibility studies with untrained operators to satisfy requirements for both application processes. The updated draft document contains recommendations for designing that single set of comparison and reproducibility studies.

In particular, the draft guidance outlines parameters of the studies, such as that testing sites are representative of the intended sites for the waived test, subject populations are representative of intended patient populations, and untrained operators are used who are representative of those who would use the device in a waived setting.

The updated draft guidance also includes recommendations for conducting quantitative testing, which provides numerical results, as well as binary qualitative testing, which provides positive verses negative or yes versus no results.

For quantitative testing in comparison studies, for example, applicants should include appropriate regression analysis, estimation of total error, and should ensure that the measuring interval of the comparative method is at least as wide as the measuring interval of the candidate test, according to the draft guidance document.

For binary qualitative testing in comparison studies, the updated draft guidance outlines how to structure testing with analytical cutoffs, as well as testing with clinical cutoffs.

The draft guidance also outlines requirements for reproducibility studies, such as that the reproducibility study should be conducted at three sites that were included in the comparison study that are representative of the intended use of the waived test, and that the same number of untrained operators at each site should be used.

The draft guidance also offers possible study designs for the evaluation of lot-to-lot variability.

Dual pathway applicants must still complete requirements unique to each approval, and dual applications contain the same information as a complete 510(k) and CLIA waiver by application.

The FDA also separately updated draft guidance on CLIA waiver applications for in vitro diagnostic devices. That updated guidance document outlines ways that device manufacturers could design studies to demonstrate that their devices are simple and accurate enough that the likelihood of error is negligible, and that they would not pose risks to patients even if they were performed incorrectly. These are key FDA requirements for CLIA-waived devices.

Both draft guidance documents were originally issued last November and have been updated based on feedback received during the original comment period. Both draft guidance documents are being re-issued to allow for additional comments. The comment period for each document will be 90 days.