The FDA is investigating how a document-management company inadvertently made public some 75,000 pages of confidential agency files about the approval of medical devices.

In addition to finalized guidance addressing software upgrades, the FDA also released finalized guidance (PDF) on making any type of change to a medical device, as well as draft guidance (PDF) on ...

Defective medical devices — and the lack of laws or enforcement against them — have killed thousands of patients around the world and put millions more at risk. Yet, in my country and many others, few ...

The Implant Files reveal TGA failures in medical device trial By Alison Branley, Mario Christodoulou, Sophie Scott and Alex Mann Background Briefing Doctors and Medical Professionals Sun 25 Nov 2018 ...

Almost 83,000 people have died around the world, including 170 in Australia in the past decade, due to potentially dangerous medical devices, an international investigation into the global device ...