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 warns consumers against using plastic syringes made in China

It’s not unusual for the US Food and Drug Administration (FDA) to publish warning letters about manufacturers that fail to meet its regulatory requirements,...

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 Proposes New Ban of Electrical Stimulation Devices for Self-Injurious or Aggressive...

Today, the U.S. Food and Drug Administration (FDA) is proposing a ban of electrical stimulation devices (ESDs) intended to reduce or stop self-injurious or...

USA – FDA drafts guidance to aid orthopedic implant guide makers

The US Food and Drug Administration (FDA) has issued draft guidance that outlines its expectations from sponsors filing premarket submissions for patient-matched guides used...

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...
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications

USA – Evidentiary Expectations for 510(k) Implant Devices

As part of FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (herein referred to as the “Safety Action Plan”), FDA committed to...

USA – FDA proposes guidance on orthopedic product coatings

The US Food and Drug Administration (FDA) wants orthopedic device sponsors to provide additional data in their premarket application if their product has a...

USA – FDA details proposed 510(k) modernization with trio of draft guidances

The US Food and Drug Administration (FDA) has announced new steps it is taking to modernize the 510(k) program, which include updates on its...

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...

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