Coronavirus Variants Spur FDA To Write New Guidance For COVID-19 Test Developers
The US agency’s immediately-in-effect guidance document – released on 22 February – explains how makers of COVID-19 diagnostics can assess whether their tests are impacted by mutations of the virus.
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The agency is cautioning that current tests may give false negative results for patients with genetic mutations of SARS-CoV-2, making it harder to control the spread of the pandemic.
Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic
On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.
The US agency has announced another month of webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.