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...
USA – FDA’s CDRH releases list of proposed guidances for FY 2024
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has named the guidance documents it plans to publish during Fiscal...
USA – FDA concerned about potential device shortages due to new EtO limits
Rural and vulnerable populations could be placed at risk as the US Environmental Protection Agency (EPA) imposes new limits on the use of ethylene...
USA – FDA issues final guidance on obtaining informed consent in drug and device...
The US Food and Drug Administration (FDA) on Tuesday announced it has finalized guidance to help institutional review boards (IRBs), clinical investigators, and sponsors...
USA – FDA recognizes new medical device sterilization standards
Amid a regulatory effort by the US Environmental Protection Agency (EPA) to limit the use of ethylene oxide (EtO), the Food and Drug Administration...
USA – FDA proposes breakthrough status for devices that address health disparities
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in...
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 – MedCon: Consider the device risk management file a ‘living document’
Device manufacturers need to keep their risk documentation up to date throughout the total product life cycle by monitoring production and post-production information, according...
USA – FDA weight-loss device guidances address clinical and non-clinical studies
A decade in the making, the US Food and Drug Administration (FDA) has published two complementary draft guidances for sponsors developing weight-loss devices. The...
USA – FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
The US Food and Drug Administration (FDA) published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) products can submit...
