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Time is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe stressed in a new status report. Read More
Some devicemakers will be allowed to continue placing their products on the EU market while they deal with the unexpected withdrawal of a notified body, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said. Read More
The FDA has released new details of its pilot accreditation scheme for medical device conformity assessments that it expects to launch later this year. Read More
Abstracts should include “a viable plan to meet requirements for the FDA to consider emergency use authorization within 12 weeks” of funding being granted, HHS said. Read More
They lawmakers urged the CDC to “prioritize localities where cases have already been confirmed, so that additional cases may be detected in real-time.” Read More
“This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health,” said FDA Commissioner Stephen Hahn. Read More
“During the grace period, if you fail to keep to the conditions, or if there is evidence of the devices not meeting the relevant safety requirements, we will withdraw the permission,” the agency said. Read More