On May 5th, the FDA added a very significant new requirement for commercial manufacturers of COVID-19 serology tests that are currently on FDA’s so-called “section IV.D list”: Submit a complete Emergency Use Authorization (EUA) Request to FDA before Monday, May 18, 2020, or FDA will remove the test from the list. Additionally, the new policy requires commercial manufacturers wishing to have their test added to the section IV.D list to submit a complete EUA Request to FDA within 10 business days of their initial application. FDA published this updated policy here (specifically, at sections IV.D and V.C of the document). This new requirement comes on top of changes last week to the EUA template for serology tests.
Having a COVID-19 serology test listed on the section IV.D list means that FDA will not object to the development and distribution of the test in the U.S. (subject to some important restrictions). Prior to May 5th, a manufacturer could have their serology tested added to the section IV.D list if they simply submitted a notification to FDA containing certain affirmations (including an affirmation that the test had been appropriately validated). FDA would then confirm receipt of the notification and add the manufacturer and their serology test to the section IV.D list.
On April 24, however, the U.S. House of Representatives Committee on Oversight and Reform took FDA to task over this section IV.D policy. The Committee was particularly upset that FDA’s section IV.D policy did not require serology test manufacturers to submit any actual validation data or other information demonstrating the effectiveness of their test. The new FDA requirements we describe above are a key part of FDA’s response to address this issue.
Accordingly, manufacturers of serology tests that are currently on the section IV.D list must submit an EUA Request to FDA by May 18, 2020, or risk removal from the section IV.D list. If a test is removed from the section IV.D list, it can no longer be distributed or used in the U.S. Additionally, manufacturers who are considering submitting an initial application to FDA to have their test added to the section IV.D list must be prepared to submit a full EUA request within 10 days of their initial application.
Our regulatory consultants and affiliated attorneys are available to help device manufacturers demonstrate the appropriate validation standards required by FDA for EUA tests. We regularly assist companies with 510(k) submissions, labeling and claims reviews, and facility registration and product listing. Contact us today to get started.
