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The version of FDA user fee legislation that’s slated to get attached to a continuing resolution (CR) later this week — just days before the end of the agency’s fiscal year — is devoid of any riders House of Representatives members and Senators worked to attach to it over the summer. Read More
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