USA – New US FDA Guidance on Human Factors Engineering for Medical Devices
The US Food and Drug Administration has issued a new draft human factors engineering (HFE) guidance this week titled: Content of Human Factors Information in...
USA – FDA proposes framework for human factors information in device submissions
The US Food and Drug Administration (FDA) last week issued draft guidance outlining a risk-based framework about what human factors information should be included...
USA – FDA aims to clarify device malfunction summary reporting requirements
In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction...
USA – Theranos : onze ans de prison contre Elizabeth Holmes, patronne déchue, condamnée...
L’ancienne star de la Silicon Valley Elizabeth Holmes, reconnue coupable de fraude en janvier, a été fixée sur sa peine, vendredi 18 novembre, près de...
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 – Industry seeks clarity, ICH Q9 alignment in FDA’s device production software...
Comments in response to the US Food and Drug Administration (FDA)’s draft guidance on software assurance for computer and data processing systems associated with...
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 – Action needed on FDA regulation of AI-based medical devices
After lagging other sectors for years, the era of artificial intelligence (AI) in healthcare is dawning as its use is becoming more prevalent in a variety...
USA – FDA advisors want standards, labeling to address racial disparities with pulse oximeters
A panel of external US Food and Drug Administration (FDA) experts are urging more research to improve the efficacy of pulse oximeters in people...
USA – FDA updates guidance on identifying and responding to deficiencies
The US Food and Drug Administration has revised the guidance document Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions to update the...
