Tuesday, May 17, 2011

Clinical trials lacking for medical devices in the UK

In the United States, the FDA oversees the clinical trials and regulations for medical devices as they would drugs.  In the UK, however, this is not the case.  Many of the medical devices brought to market in the UK are lacking in clinical trail data to prove their efficiency and safety.  To support this, there were 757 recalls of medical devices in the UK in 2010 alone.  When the Guardian asked those device manufacturers for clinical data on those recalls, only 2% of companies could provide that information to them.

Is this something the UK needs to regulate?  Without proving the device performs as it should as well as proving its safety, should patients in the UK demand regulation on the medical devices they're using?

Partnerships in Clinical Trials is a global brand that examines how to Pharma companies can best partner with clinical research organizations around the world to efficiently conduct clinical trials for drugs and medical devices. Global regulatory challenges in conducting clinical trials is one of several critical themes discussed at this annual meetings. Partnerships in Clinical Trials Latin America is taking place in Sao Paulo, Brazil; on August 1-3, 2011 and Partnerships in Clinical Trials Asia is taking place in Shanghai, China this October 12-14, 2011.




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