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FDA-authorized antigen tests for the virus that causes COVID-19 appear to work for the omicron variant but they may have less sensitivity for identifying positive samples, the agency said. Read More
The FDA has released final guidance detailing the core components of nonclinical testing and clinical trials of benign prostatic hyperplasia (BPH) devices, citing the condition’s prevalence in older male populations. Read More
The FDA is receiving more than 100 applications for pre-Emergency Use Authorization (EUA) meetings and full EUA status for in vitro diagnostics (IVD) each month, so it expects to receive more than 1,000 such submissions in 2022. Read More
The FDA has issued a draft guidance explaining how it defines and distinguishes “counterfeit” devices from the genuine article, as part of its implementation of the Safeguarding Therapeutics Act enacted Jan. 5. Read More
The FDA is looking to regularize the status of devices it has authorized for emergency use during the COVID-19 pandemic and has released two draft guidances — one explaining the transition away from emergency status and another on how the agency’s approach to enforcement will change for the affected devices. Read More
Citing the COVID-19 pandemic and other obstacles, the European Union has pushed back the dates by which manufacturers must comply with the EU’s IVD Medical Devices Regulation (IVDR). Read More
The European Commission has issued a regulation that will allow devicemakers to distribute instructions for use (IFUs) in electronic format, playing catch-up with the FDA and other international regulatory agencies that have already allowed devices to be accompanied by electronic-only instead of paper instructions. Read More
Sponsors of devices already cleared through the FDA’s 510(k) pathway that wish to gain approval for changing the sterilization method they use may find it easier to do so under a new pilot program the agency is considering. Read More
Dental Technologies of Lincolnwood, Ill., drew an FDA warning letter for not adequately investigating a manufacturing problem, among other quality violations. Read More