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The European Commission has released the first opinion by an expert panel assessing a product for compliance with the EU’s In Vitro Diagnostics Regulation (IVDR), which will go into effect on May 26, 2022. Read More
Invacare has received a warning letter from the FDA for — among other failures — not fully investigating an incident in which a patient who was using one of its oxygen concentrators had to be taken to the hospital in an ambulance because the device wasn’t producing enough oxygen. Read More
Sixty-one senators of both parties have sent a letter urging the Centers for Medicare & Medicaid Services (CMS) to find a way for Medicare to pay for breakthrough medical devices, after the agency withdrew a previous proposal to do so. Read More
The FDA is planning to reclassify HIV viral load monitoring tests from high-risk class III devices requiring premarket agency approval into lower-risk class II devices requiring special controls and a premarket notification. Read More
In a final order published yesterday, the FDA reclassified general laparoscopic power morcellation containment systems as class II medical devices requiring “special controls,” including specified training, labeling and a boxed warning. Read More
The World Health Organization (WHO) and the Medicines Patent Pool (MPP) announced Tuesday they have reached a licensing agreement with the Spanish National Research Council for a COVID-19 antibody test that they will make freely available. Read More
Elizabeth Holmes is testifying this week in her own defense in her trial for fraud connected with the failure of Theranos, the blood testing diagnostics company she helped found. Read More
The United Kingdom is reinventing its medical device regulatory framework now that it’s no longer in the European Union, and the country’s Medicines and Healthcare products Regulatory Agency (MHRA) is asking for public comment on “possible changes to the regulatory framework” for devices. Read More
A federal judge has cleared Pfizer’s $345 million settlement resolving claims the drugmaker overcharged for its EpiPen epinephrine self-injector for treatment of severe allergic reactions. Read More
The FDA’s Safer Technologies Program (STeP) for Devices provides similar agency resources and priority review to sponsors whose devices do not meet the criteria for breakthrough status. Read More
HHS withdrew a temporary policy yesterday that directed the FDA not to enforce its premarket review requirements for laboratory developed COVID-19 tests — an emergency policy that was put in place to get tests quickly into use during the pandemic. Read More