The FDA has laid down a path for the developers of COVID-19 tests and other pandemic-focused medical devices to finally make the transition to the foreseeable regulatory future, where the coronavirus will be treated as more endemic than emergency—and the agency is urging companies to get their paperwork in ASAP.
That includes the holders of more than 950 authorizations granted over the past three years, spanning more than 430 different devices for diagnosing, treating or preventing COVID-19—everything from at-home tests, to hospital ventilators, to face masks—who will need to secure full FDA green lights to keep selling their products, the FDA’s device center director, Jeff Shuren, said in a release.
Through a pair of newly finalized guidance documents, the agency said it aims to help companies navigate the legal requirements that may shift after the U.S. government formally rolls back its public health emergency authorities—including those that “may or may not want to continue to distribute” their products going forward.
“We recognize that it will take time for device manufacturers, device distributors, health care facilities, health care providers, patients, consumers, and the FDA to adjust from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations,” Shuren said.
And though he pointed to a six-month transition period to help avoid disruptions in device supplies, the Friday announcement included a clear, bolded headline, stating: “Manufacturers Should Submit Marketing Submissions Now.”
Shuren also encouraged companies to “use this transition period wisely, and submit a pre-submission, if needed,” and employ electronic templates for the documents necessary to obtain 510(k) or de novo product clearances.
The FDA said late last year it would start throttling back its emergency authorization efforts, to help push the industry to get ahead of the upcoming policy changes. That included urging all companies to submit full product applications, while only allowing a small subset of applications to proceed under emergency review.
The agency said those authorizations would be reserved for specialized products, such as diagnostics employing new technologies or aimed at unmet medical needs—for example, the emergency green light bestowed just last month to its first over-the-counter test that checks for both COVID-19 and the flu, developed by Lucira Health.
In its final guidance documents, first issued as drafts in December 2021, the FDA said that manufacturers should continue to comply with the terms of their emergency use authorizations until they are officially terminated.
Though the Biden administration is set to declare an end to the COVID-19 public health emergency in May, that may not bring immediate changes to the separate regulatory declaration that governs many currently available coronavirus tests, treatments and vaccines.
For emergency-authorized products already on the market, the FDA recommends manufacturers include a “transition implementation plan” in their submissions for a full marketing green light—estimating the number of products that are already in U.S. distribution, and an explanation of the potential risks if that green light is denied.
Once a company has their marketing submission in for review, the FDA said it plans to not object to certain cases where products may still be on the market in the time between the end of an emergency authorization and a final regulatory decision.
And for companies that plan to no longer continue offering their products after the switch, the FDA suggested they complete the withdrawal of those devices from the market before their authorization is terminated.