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COVID-19 Update for Diagnostic Device Manufacturers

The availability of Coronavirus Disease-2019 (COVID-19) diagnostic tests is critical to an effective response to the current pandemic. FDA has taken measures to permit the distribution of such tests in advance of receiving authorization to do so from the agency in an attempt to remove bureaucratic barriers that could affect the nation’s ability to mount a timely response.  

Yesterday, FDA implemented a policy that would permit the distribution of Coronavirus Disease-2019 (COVID-19) diagnostic tests in advance of receiving marketing authorization from the agency. The policy is titled “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency – Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff” and can be viewed at this link: https://www.fda.gov/media/135659/download

For commercial manufactures that seek to develop and distribute a COVID-19 diagnostic test, the policy permits such distribution provided the test has been validated and that the entity responsible for its distribution notifies FDA that it is validated. The entity then has 15 days to submit an application for an Emergency Use Authorization (EUA) request for the test. FDA has indicated that it will review submitted EUA requests and work with the submitter to resolve any problems with the test’s performance data. In the case that there are significant problems with the performance data or problems that cannot be addressed in a timely matter, FDA expressed the expectation that the submitter will cease distribution and conduct a recall of the test.

This policy also includes similar opportunities for CILA-certified laboratories seeking to perform high-complexity testing using their validated tests as well as commercial manufacturers seeking to distribute serology tests.

Significantly, the policy permits individual states to perform such tests within the state under the authority of that state’s law independently of any FDA requirements.  

If you have any questions about this policy or have such a product, feel free to contact us.

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