Source:  perspectives.3ds.com

New FDA Commissioner Adamant About Unique Device Identifiers (UDI)

By: Ellyn McMullin, Research Associate and Daniel R. Matlis, President

UDI Implementation – The Key to Unlock Personalized Medicine? 

The Senate has confirmed Cardiologist Robert M. Califf as FDA Commissioner.

Source: Medscape.com

Source: Medscape.com

During his confirmation hearing, Dr. Califf stated that “he is adamant about the use of identification numbers on medical devices (UDI) that will enable the FDA to spot whether device issues are minor glitches or major safety-endangering malfunctions.”

The implementation of Unique Device Identification (UDI) is having a profound effect on Med-Tech manufacturers, healthcare providers, regulators and ultimately the patient. The 7-year compliance timeline reached its second milestone on October 24, 2015.  As of that date the labels and packages of implantable, life-supporting and life-sustaining devices must bear a UDI and date.  Furthermore, software that is classified a life-supporting or life-sustaining device must include a UDI.

Could UDI be a key that unlocks the potential of personalized medicine for the masses?

Please click here to request a copy of the white paper: UDI Implementation – the Key to Unlock Personalized Medicine?

 

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