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“It is not reasonable to believe that the test may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the test outweigh the known and potential risks of the test,” the agency said. Read More
“Manufacturers must be able to demonstrate how they have met the high levels of safety and performance expected from all medical devices,” the agency said. Read More
A Seattle-based study of how COVID-19 spreads through the community has put its project on hold at the FDA’s request until it receives an Emergency Use Authorization (EUA) for its lab-developed test and self-swab kit. Read More
The FDA has released a new Emergency Use Authorization (EUA) template to help devicemakers develop COVID-19 tests for at-home self-collection. Read More
The FDA’s changes in response to the COVID-19 outbreak will lead to permanent improvements at the agency, predicts FDA Commissioner Stephen Hahn. Read More
The FDA has released a new Emergency Use Authorization (EUA) template to help devicemakers develop COVID-19 tests for at-home self-collection. Read More
The European Commission’s Medical Device Coordination Group (MDCG) outlined in a new guidance how devicemakers should report safety incidents for clinical studies under the new Medical Device Regulation. Read More
TEAM-NB, the European Association of Notified Bodies for medical devices, reported that CE certificates spiked by nearly 50 percent last year. Read More
The FDA’s changes in response to the COVID-19 outbreak will lead to permanent improvements at the agency, predicts FDA Commissioner Stephen Hahn. Read More