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The FDA clarifies its regulatory approach to clinical decision support (CDS) software and gives examples of what it considers non-device CDS software in a final guidance published yesterday. Read More
The FDA is now prioritizing its review of Emergency Use Authorization (EUA) requests on a smaller subset of experienced developers applying for tests that are likely to have either a significant public health benefit or fulfill an unmet need, according to final guidance released by the agency Tuesday. Read More
Artivion’s study of its On-X mechanical aortic valve with the anti-clotting drug apixaban rather than warfarin was halted early for futility. Read More
Observations from the FDA’s Software Precertification Pilot Program confirmed that the rapidly evolving device software category needs a new “regulatory paradigm,” the agency said in a report on the now-completed pilot. Read More
Zuga Medical did not properly investigate hundreds of complaints about failures of its dental implants over a five-year period, the FDA said in a Form 483 issued after a March 24 to April 12 inspection of the company’s Chagrin Falls, Ohio, facility. Read More
Siemens Healthcare Diagnostics delayed responding to complaints about several of its devices not working properly for months on 12 occasions and also delayed notifying the FDA and correcting the problems. Read More
The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations. Read More
Reauthorization of FDA’s user fee legislation moved ahead a step last week as leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee agreed to include a slimmed-down version of user fee legislation and smaller policy riders on a short-term government funding bill, or continuing resolution (CR). Read More