NEW YORK (360Dx) – The US Food and Drug Administration has released a new draft guidance document on applying for Clinical Laboratory Improvement Amendment waivers, including recommendations for making the dual CLIA waiver and 510(k) clearance pathway less burdensome.
The dual 510(k) and CLIA waiver application pathway was first established as part of the Medical Device User Fee Amendments of 2012. The FDA believes the dual pathway is the fastest and least burdensome approach for manufacturers, however, most manufacturers currently follow a sequential approach, though which a CLIA waiver follows clearance or approval of an in vitro diagnostic device, according to the agency.
The new draft guidance "leverages FDA's experience" implementing dual submissions in order to make the dual submission pathway "least burdensome," according to the agency. "Use of this guidance is expected to reduce study-related costs and provide time savings for manufacturers of certain Class I and II IVD devices intended for CLIA-waived settings," the FDA said.
Specifically, the draft guidance includes recommendations for designing a single set of comparison studies so that data generated from the studies will support both 510(k) clearance and CLIA waiver applications.
The FDA recommended in the guidance that a dual submission include a device description and determination that the device is "simple," a risk analysis for the device, a description of failure-alert and fail-safe mechanisms, results of flex studies, and analytical, comparison, and reproducibility studies, as well as proposed device labeling.
A separate draft guideline document also released on Tuesday provides additional recommendations to manufacturers of in vitro diagnostic devices for demonstrating accuracy when following a sequential route for a CLIA waiver. The draft guidelines cover two options for demonstrating that an in vitro test has "insignificant risk of erroneous result," which is key for getting a CLIA waiver.
Under the first option, "If the sponsor chooses to demonstrate the accuracy of the test when performed by trained operators as part of the marketing submission through comparison to a traceable calibration method (or reference method), the sponsor can leverage these data in combination with a new study to demonstrate agreement between results of the test performed by untrained operators and trained operators in the waiver by application submission," according to the guidance.
Under the second option, "If the sponsor chooses to demonstrate substantial equivalence or safety and efficacy for the test when performed by trained operators in the marketing application without demonstrating accuracy through a comparison to a traceable calibration method (or reference method), the sponsor should 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."
Both draft documents have 60-day comment periods.
The FDA also said that it will hold a webinar on Jan. 8, 2018 to discuss and answer questions about the these draft guidance documents.