FDA says backlog of non-COVID applications will be cleared in eight weeks

The FDA’s Center for Devices and Radiological Health (CDRH) has had its hands full with the COVID-19 pandemic, which has led to an accumulation of non-COVID premarket applications that has hampered access for patients and industry alike. In a new entry at the FDA Voices blog, the agency said that backlog will be gone in eight weeks if all goes well, thanks in large part to smarter management of COVID-related regulatory filings. The number of non-COVID filings reached 17,000 in 2020, the agency said, which includes pre-submission items in addition to 510(k)s, PMAs and de novo petitions, although emergency use authorization (EUA) filings added another 5,500-plus entries. At present, roughly 600 EUA submissions are in process with another 40 arriving each week, but smart use of guidance and templates has allowed FDA staff to sort through these submissions efficiently. More than half of those employed at CDRH have spent at least some of their clock time on EAU submissions, which has necessitated a lot of evening and weekend work. The agency said some product areas have suffered more than others, but vowed to process all these filings expeditiously, even though work related to the pandemic remains a priority.

NIH awards $33M for return-to-school efforts

The U.S. National Institutes of Health announced it will award funds totaling $33 million over two years to establish frequent COVID-19 testing protocols at underserved schools in an effort to advance return-to-school measures. The 10 awardees, located in eight U.S. states, will receive antigen and molecular tests to be deployed in the home and/or at schools, the latter of which will use the tests on pooled samples. The agency said additional awards will be made in the coming months.

Advamed tells CMS not to delay on MCIT

The Advanced Medical Technology Association (Advamed) said in an April 15 letter to Elizabeth Richter, acting director of the Centers for Medicare & Medicaid Services, that the agency should not delay enacting the final rule for the Medicare Coverage of Innovative Technology (MCIT) program. Advamed’s chief strategy officer, Andrew Fish, said the coverage of FDA breakthrough device applications should not be held up pending the proposed revision of the definition of “reasonable and necessary,” adding that the newly created office for coding can handle the associated issues with coding and rate-setting. Fish disputed the administration’s contention that the issuance of a proposed rule for durable medical equipment should hamper, adding that of the 400 or so devices that qualify for the breakthrough devices program, only 23 have been granted marketing authorization that would qualify for the MCIT program. That number includes devices that were brought to market in the legacy expedited review program that formed the base of the breakthrough devices program, and Fish said that this amounts to four devices per year, given that the expedited review program began six years ago.