FDA Watch: Extra Time for Comments on CLIA IVD Waiver Proposals

Securing CLIA waivers for in vitro diagnostic (IVD) medical devices from the FDA is a time-consuming and cumbersome process So, the FDA won rare plaudits from the industry on Nov. 29, 2017, by setting out a pair of draft guidance documents proposing to loosen up the rules. The original deadline for comment was 90 days from publication. But at the end of January, the agency announced that it was pushing the deadline back to March 30. Here’s a down and dirty on each proposal.

The Demonstrating Insignificant Risk of Erroneous Result Draft Guidance
The first draft guidance lays out two options sponsors can use to demonstrate accuracy, i.e., "insignificant risk of erroneous result," of in vitro diagnostic tests for purposes of obtaining a CLIA waiver:

  • Demonstrate accuracy of the test when performed by trained operators as part of the marketing submission via comparison to a traceable calibration (or reference) method and then leveraging the data in combination with a new study to demonstrate agreement between results of the test performed by untrained and trained operator in the waiver by application submission; or
  • Where the sponsor chooses to demonstrate the test’s substantial equivalence or safety and efficacy when performed by trained operators in the marketing application without demonstrating accuracy via comparison to a traceable calibration (or reference) method, "the sponsor [may] demonstrate accuracy of the test when performed by untrained operators through direct comparison to a traceable calibration method (or reference method), or other comparative method performed in a laboratory setting by trained operators in the waiver application."

The Dual Pathway Draft Guidance
The second draft guidance aims to make the dual CLIA waiver and Section 510(k) clearance pathway for certain Class I and Class II IVD devices created in 2012 less burdensome. Among other things, the guidance recommends that manufacturers include as part of a dual submission:

  • A device description and determination that the device is "simple";
  • A risk analysis for the device;
  • A description of its failure-alert and fail-safe mechanisms;
  • Results of flex, analytical, comparison and reproducibility studies; and
  • Proposed device labelling.

Takeaway: Reading between the lines and based on previous agency activity, extension of the comment periods could be a positive sign presaging quick adoption of both proposals. On the other hand, the delay could just be attributable to the timing of the original comment period during the holiday season and calendar wrap around. So stay tuned.


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