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The FDA will focus its regulatory authority on a subset of software functions that are medical devices and could pose a risk to patient safety if they do not act as intended, the agency said in a final guidance published Wednesday. Read More
The FDA said it won’t enforce former Federal Food, Drug and Cosmetic Act (FD&C) requirements for certain medical device data systems (MDDS), medical image storage devices or medical image communication devices, in a final guidance released yesterday. Read More
In comments on the third installment of the FDA’s draft guidance on patient-focused drug development, AdvaMed has recommended that the guidance not apply to medical devices — although the industry association says it supports the overall use of patient experience measures as clinical trial endpoints. Read More
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
The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations.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
The FDA needs to revise its Emergency Use Authorization (EUA) policies for tests of future infectious disease outbreaks, the HHS Office of Inspector General recommends in a new report. Read More