AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

Dispositifs Médicaux – AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology...
Verification Systems: FDA Drafts Guidance on What to Include

USA – FDA Issues Two Final Guidances on Communications Not Included In Product Labeling

Last month, FDA issued two final guidances on medical product communications, including communications by medical device companies about unapproved uses of approved/cleared medical products:...
FDA Approves First Generic Versions of EpiPen

USA – FDA Approves First Generic Versions of EpiPen

The US Food and Drug Administration on Thursday approved Teva Pharmaceuticals’ first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency...
FDA Approves First Contraceptive Mobile App

USA – FDA Approves First Contraceptive Mobile App

A Swedish startup company obtained US Food and Drug Administration (FDA) approval Friday for the country’s first mobile medical app indicated for contraceptive use. The...
AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

USA – FDA Targets Unapproved Vaginal Rejuvenation Devices

The US Food and Drug Administration (FDA) on Monday warned patients and healthcare providers against using energy-based devices involving radiofrequency or lasers for vaginal...
AngioDynamics to Pay $12.5M to Settle Allegations

USA – AngioDynamics to Pay $12.5M to Settle Allegations Over Two Unapproved Devices

Devicemaker AngioDynamics recently agreed to pay the US government $12.5 million to settle false claims allegations involving two medical devices. The settlement resolves a 2013...

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