The names of the products and their manufacturers are now on a “removal list” as they are not in compliance with new regulatory requirements announced by the agency this month. It includes products that have been voluntarily withdrawn and products that have not been cleared through the FDA’s emergency use authorization (EUA) pathway. Critics have been alarmed at what they saw as a lax regulatory approach during the pandemic, resulting in the market entry of many tests for immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies that had never been validated or reviewed. The agency responded by changing its policy to require commercial manufacturers to submit EUA requests within 10 business days from the date that they notified the agency of their validation testing. The FDA also now has specific performance thresholds that testing products must meet.
In a statement about its publication of the removal list, which was published May 21 on a section of the FDA website pertaining to the availability of tests, the agency said that it is “providing promised transparency for antibody tests.”
The products on the list are as follows:
- Artron BioResearch/Artron Laboratories,…
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