ARTICLE SUMMARY:
FDA takes several key steps on post-pandemic transition pathways. Excerpted from Pathways' Picks March 15: MDR Ahead, COVID Transition, FDA Budget.
A COVID-19-era guidance that allows companies to make certain device design and manufacturing modifications without an FDA supplement submission will be retained for the long-haul in a revised form, the agency affirmed March 10. FDA also says it plans the same approach for three other device guidance documents that were originally linked to the duration of the COVID-19 public health emergency (PHE). The White House recently signaled plans to let the PHE expire on May 11, prompting FDA to issue the March 10 notice disclosing the fate of 72 guidance documents that were issued since 2020 as short-term emergency pandemic policies. In 2021, the agency issued a draft guidance, which will be finalized soon (see next brief), outlining a transition plan for such COVID-19 “enforcement discretion” policies, keeping them in place for at least 180 days after the PHE expires. FDA affirmed that approach in last weeks’ notice; no device guidances were on the list of documents slated for immediate retirement May 11. Fifteen device documents, meanwhile, were officially set to retire at about the 180-day post-PHE mark to allow for a wind-down period. And then there were the four documents FDA says it will revise during that 180-day period and then keep some versions of the enforcement flexibilities active over the long haul. Those address:
- Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions
- Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
- Clinical Electronic Thermometers
- Face Masks and Barrier Face Coverings
The recent notice also affirmed the distinct status of two guidances that outlined FDA’s policies for COVID-19 tests, which are no longer tied to the PHE, but instead are linked to a distinct HHS declaration allowing Emergency Use Authorizations (EUAs) for IVDs.
Transition docs coming soon. Also on March 10, the agency submitted final versions of documents laying out the device center’s specific post-COVID-19 transition plans to the White House Office of Management and Budget (OMB) for pre-release review. One of the guidance documents details general procedures for the enforcement discretion policies discussed above and the other describes plans for converting the hundreds of COVID-19 EUAs FDA has granted over the past three years to either traditional regulatory pathways or off the market. The timing suggests the final guidances could come out before the Biden administration allows the COVID PHE to end in May.
COVID De Novo. The EUA transition guidance is intended to support stability as companies that want to continue to market emergency-authorized COVID-19 tests seek conventional regulatory clearance. Progress on that front has already begun, including this past week, when FDA granted a De Novo authorization to Quidel’s previously emergency-authorized Sofia 2 SARS Antigen+ FIA assay—the first COVID antigen test to make it through a traditional FDA premarket review process. FDA already granted a De Novo to a molecular COVID-19 test in 2021 and has since followed with several molecular test 510(k)s. (See “The COVID De Novo Path Blazed by BioFire,” Market Pathways, April 12, 2021.)
CDRH sends “misinformation” response. Meanwhile, the device center isn’t done reviewing COVID-19 EUAs. Last month, it granted an EUA to the first over-the-counter, home-use dual COVID/flu test, developed by Lucira Health. But the timing was rough for the company, which had just entered Chapter 11 bankruptcy a few days before the EUA came through. Lucira’s CEO said a “protracted” FDA process was a key driver behind the firm’s decision to cut its losses (it plans to sell the business). In response, on March 7, CDRH issued an extremely unusual statement from director Jeff Shuren, conveying details about the Lucira review process in an effort, he said, to “address misinformation.” The statement pointed to problems with the company’s originally submitted product and noted the agency’s willingness to accept fewer samples than what was recommended in its EUA template.
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