USA – Quinze ans de prison requis contre Elizabeth Holmes, fondatrice de Theranos

Les procureurs ont requis 15 ans de prison contre Elizabeth Holmes, star déchue de la Silicon Valley, tandis que la défense a plaidé pour une...
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

USA – FDA Details Long-Awaited Standards Accreditation Pilot in New Draft Guidance

The US Food and Drug Administration (FDA) on Friday issued draft guidance outlining its much-anticipated voluntary conformity assessment pilot, known as the Accreditation Scheme...

USA – FDA rules on definitions of device; issues revised form for reporting adverse...

The US FDA has issued final guidance clarifying how the agency interprets existing references to section 201(h) of the FD&C Act and how the agency intends...

USA – Device, digital health firms oppose HHS’ proposed 510(k) exemptions

Medical device and digital health companies have largely come out in opposition to a proposal from the Department of Health and Human Services (HHS)...
Microfluidic Device Corrals Viable Sperm for IVF

USA – Microfluidic Device Corrals Viable Sperm for IVF

Researchers at Cornell University have developed a microfluidic device to rapidly isolate the strongest and fastest sperm from a sperm sample. The technique should...

USA – Legal expert: FDA’s CDS software guidance is a ‘disaster’ for industry

The US Food and Drug Administration’s (FDA) final guidance on clinical decision support (CDS) software goes against the statutory language laid out in the 21st Century...

USA – FDA final rule reduces radiological devices reporting requirements

The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays....

USA – US FDA rolls out list of registered medical devices featuring artificial intelligence...

The US Food and Drug Administration has published an initial list of legally marketed medical devices that utilize artificial intelligence and machine learning (AI/ML)...

USA – Voluntary consensus standards guidance updated by FDA

Voluntary consensus standards guidance updated by FDA The US Food and Drug Administration has issued a final guidance addressing voluntary consensus standards, updating a September...
FDA teams with India to stop counterfeit shipments

USA – FDA teams with India to stop counterfeit shipments

The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit,...

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