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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
Sponsors musts report any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, the group said. Read More