FDA provides path for diagnostic testing using pooled samples
The FDA announced it had amended the emergency use authorizations for several diagnostic tests for the SARS-CoV-2 virus to allow serial pooled testing for anterior nasal samples in serial testing programs. The agency said it will add a diagnostic test to the list of tests authorized for developers that have self-certified its validation of a test for this use. Test developers must submit notification that includes the validation data, assuming the pooling is for more than three specimens. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said the agency “will continue to prioritize authorization for tests with the ability to increase testing accessibility or to significantly increase testing capacity.”
FDA inks warnings for pandemic testing
The FDA posted five warning letters to companies for marketing tests for the COVID-19 pandemic without an emergency use authorization or conventional premarket review, such as the March 18 warning to Block Scientific Inc., of Bellport, N.Y. The agency requested that Block respond to the warning within 48 hours, a much shorter time than the 15 working days ordinarily accorded recipients of warning letters. Also receiving warning letters with a 24-hour turnaround request were Tresmonet Technologies Inc., of New Orleans, Ikcon Investments Inc., of San Diego, Sethi Labs, of Dallas, and Fast Masks USA LLC, of Grapevine, Texas.
Recall issued for repaired infusion pumps
The FDA said Tenacore Holdings LLC, of Santa Clara, Calif., has recalled infusion pumps serviced by the company due to bezel repair posts that may crack or separate. The issue can lead to inaccurate delivery of fluids to patients, although no complaints, injuries or deaths have been reported. Tenacore recommends that customers quarantine all affected product pending replacement of the bezels. The recall affects 474 devices repaired between February 2018 and July 2020.
NICE launches transformative strategy
The U.K.’s National Institute for Health and Care Excellence (NICE) is launching a five-year strategy to provide quicker patient access to new treatments and innovative technologies. The strategy calls for rapid, robust and responsive technology assessments; dynamic guideline recommendations that integrate the latest evidence, technologies and practice; increased use of the guidance, with monitoring and measuring of the impact it has on health outcomes; and the use of real-world data to fill gaps in knowledge and drive patient access to innovations. Noting how COVID-19 has changed the U.K.’s healthcare landscape, NICE said the “pandemic provided a catalyst for the type of change that we already knew we needed to make.” The goal is to ensure NICE is more proactive and engaged with the life science industry earlier in the innovation pathway so patients will have access to new treatments faster.
Russia expands access to certain pediatric treatments
As part of its Circle of Kindness Foundation, the Russian government approved a process for the purchase of drugs and medical devices, including those not registered in Russia, for a specific child with a serious life-threatening and chronic disease, including rare diseases, or for groups of such children. The government developed a list of products it will cover under the program.