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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
When determining whether to issue an EUA for a multi-analyte respiratory panel that includes SARS-CoV-2, the agency said it considers the clearance or approval status of diagnostics for the other analytes on the panel. Read More