Center for Devices and Radiological Health (CDRH) Archives

CDRH’s Shuren says they’re ‘starting to turn the corner’ from COVID-19

CDRH director Dr. Jeff Shuren [Image courtesy of FDA]Medical device industry insiders will have to wait until the new year to get a better idea of the post-pandemic priorities at the FDA’s CDRH.

That was one of the big takeaways from Dr. Jeff Shuren’s remarks at the virtual CDRH Town Hall held yesterday at AdvaMed’s The MedTech Conference, which takes place this week as a combination of virtual presentations and live presentations events in Washington, D.C., and Minneapolis.

Shuren, the director of FDA’s Center for Devices and Radiological Health, said the center is “starting to turn the corner” on catching up on submissions. Additional funding from Congress, he said, allowed CDRH to bring on more people, leverage contractors and make changes in policy and process.

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FDA issues mea culpa for early COVID-19 serology test nods

(Image by the National Cancer Institute on Unsplash)

Early in the pandemic, when the numbers of asymptomatic COVID-19 cases were mounting, officials at the FDA decided to authorize the use of serology tests that laboratories had validated but that the agency hadn’t actually reviewed.

Now two FDA officials are admitting that this was a mistake, but one the agency has learned from. In an article published in the New England Journal of Medicine, two top officials of the FDA’s Center for Devices and Radiological Health (CDRH) said that the agency was trying to slow the spread of SARS-CoV-2, the virus that causes COVID-19, by using the results of serology tests to screen for antibodies for the virus.

Get the full story on our sister site, Medical Design & Outsourcing.

FDA adds reference panel to study COVID-19 diagnostics

The FDA has released a new reference panel to evaluate diagnostic tests for COVID-19.

Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration and monitoring of assay performance, according to the agency.

Nucleic acid tests identify infection by confirming the presence of a virus’ genetic material (RNA), and the FDA said its new reference panel provides developers access to this material.

The agency described it as an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. It is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process.

“The FDA has taken many steps during this pandemic to ensure that Americans have access to trustworthy diagnostic tests,” said Jeffrey Shuren, director of the FDA’s Center for Devi…