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The European Commission’s Medical Device Coordination Group announced that a new Eudamed registration module will go into effect on December 1, enabling users to create a unique single registration number (SRN). Read More
In further Brexit fallout, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) said Sept. 1 that devices with the CE mark will continue to enjoy UK recognition until June 30, 2023. Read More
Australia’s Therapeutic Goods Administration move to exempt from regulation certain classes of software-based medical devices that present a lower risk to safety drew broad support in written comments to the agency. Read More
The FDA has revoked the emergency use authorization (EUA) for protective barrier enclosures used by healthcare providers when caring for patients thought to be infected with COVID-19 to prevent exposure by providing an extra layer of protection in addition to personal protective equipment. Read More
The FDA issued an update on adverse events related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and breast implant illness. Read More
The European Commission’s Medical Device Coordination Group announced that a new Eudamed registration module will go into effect on December 1, enabling users to create a unique single registration number (SRN). Read More
In a dramatic policy reversal instigated by President Trump, the FDA will no longer require lab-developed tests (LDTs) for COVID-19 to undergo premarket review, the Department of Health and Human Services (HHS) announced Aug. 19. Read More