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The FDA is expanding the applications that can be made using its electronic Submission Template and Resource (eSTAR) filing system from 510(k) clearance requests to include de novo device applications. Read More
There are no one-size-fits-all methods for modeling cybersecurity threats facing medical devices, but developers and manufacturers of medical devices can help mitigate the threats by considering four simple questions suggests a new “playbook” endorsed by the FDA. Read More
Medical device recalls increased by more than 35 percent to 235 incidents in the third quarter of 2021, up from just 173 in the second quarter, reversing a year-long trend of declining numbers, a new analysis suggests. Read More
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