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FDA Cracks Down on Unauthorized and Counterfeit COVID-19 Diagnostic Tests

As the COVID-19 public health emergency drags into its third year, we continue to keep track of efforts by the Food and Drug Administration (FDA) to combat fraud in the form of fake cures, counterfeit diagnostic tests, and other products claiming to prevent, treat, or detect infection by SARS-CoV-2 that are marketed without required FDA authorization. Our previous posts (see here and here) provided updates on joint and separate efforts by FDA and the U.S. Federal Trade Commission (FTC) throughout the pandemic to detect and eliminate these illegal products. In this post, we focus on FDA’s recent enforcement activities concerning COVID-19 diagnostic tests and the agency’s increasingly aggressive pursuit of entities offering counterfeit or unauthorized tests.

From one perspective, FDA appears to have pumped the brakes on enforcement activities relating to COVID-19 tests. Although the agency issued 15 Warning Letters to companies offering unauthorized tests between January 1 and July 31 of 2021, only two such letters issued since August 1, 2021 appear in FDA’s Warning Letter database. However, FDA’s device recall database tells a completely different story and serves as a striking reminder that such letters are not the only metric to consider when it comes to the agency’s enforcement powers.

Notably, since August 1, 2021, companies initiated 40 recalls for COVID-19 test products classified under product codes QLT, QKP, QJR, and QKO. By comparison, companies initiated a total of 89 recalls for products in the same device classifications when we look back over the course of the entire pandemic (i.e., starting in March 2020). Furthermore, FDA has designated 17 of the 40 recalls commenced since August 1, 2021 as Class 1 recalls (the highest risk classification for a recall of an FDA-regulated product), whereas only 23 recalls for these same product codes have been designated as Class 1 since the start of the pandemic. The fact that just over 40% of the recalls for COVID-19 tests were initiated in the past nine months and that almost half of those recalls are Class 1 illustrates FDA’s zeal to root out poor quality and unauthorized tests from the U.S. marketplace. Indeed, most of the Class 1 recall descriptions state that the diagnostic test products are being removed from the market because they did not receive authorization from FDA.

We understand from FDA’s prior enforcement actions that the agency has formed a dedicated COVID-19 product compliance task force that scours company and product websites, advertisements, and other materials to identify potentially violative products. As we previously reported, the most recent version of FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency requires clinical laboratories to obtain emergency use authorizations (EUAs) for their laboratory-developed COVID-19 tests. Since issuing that revised policy on November 15, 2021, the agency has also been actively investigating clinical laboratories that appear to have distributed specimen collection kits or performed COVID-19 testing in violation of FDA policies or specific test product authorizations, including the authorized instructions for use. Furthermore, we are aware that FDA is reaching out to diagnostic companies and clinical labs to question statements made on their websites relating to COVID-19 tests and to request details regarding test distribution and workflow, a process that may result in an unofficial finding of noncompliance and request for corrective action (which, in some cases, may include a recall).

In addition, on April 29, FDA added a new Counterfeit At-Home OTC COVID-19 Diagnostic Tests page to its website, which provides helpful information for identifying unauthorized or counterfeit tests and includes a list of all COVID-19 tests the agency has identified as counterfeit.

Another interesting statistic for COVID-19 test products as we move into another summer under the pandemic is the number of tests that have transitioned from EUA status to full FDA clearance or approval. As of the date of this blog post, FDA has given authorization for one COVID-19 test under the De Novo classification pathway and cleared one other test under the 510(k) pathway. Both marketing authorizations are held by one company, called Biofire. Multiple factors had suggested that manufacturers would start submitting 510(k) notifications, De Novo classification requests, or premarket approval applications (PMAs) for COVID-19 test products, including demands from customers that tests have FDA clearance or approval, public skepticism of the EUA process, and Biofire having done the heavy lifting to obtain the first De Novo classification allowing others to submit 510(k)s using Biofire’s device as a predicate. In addition, FDA issued guidance in December 2021 describing the agency’s plans to transition medical devices currently being marketed pursuant to EUAs and those meeting enforcement policies during the COVID-19 public health emergency, which included expected timelines for manufacturers to obtain full clearance or approval for such devices. However, in April 2022, the Department of Health and Human Services extended the public health emergency by another 90 days, allowing device manufacturers additional time to assess their regulatory strategies and to consider preparing submissions for their COVID-19 test products. Given the current states of both the pandemic and the market for COVID-19 tests, it is very likely that FDA will experience a surge of regulatory submissions for diagnostic test products once the public health emergency ends. To avoid delays and potential exclusion from the market, COVID-19 test manufacturers should plan to transition to full marketing authorization sooner rather than later.

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Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.