UDI stands for a unique serial number given to each medical device. In this scenario, each identical device would be assigned its own serial number which becomes easy to track it through out its life cycle.
On Feb. 12, the U.S. Food and Drug Administration convened a public workshop on development of a unique device identification system for medical devices under the FDA Amendments Act of 2007, which mandates the UDI.
As part of the FDA Amendments Act of 2007 (“FDAAA”), FDAAA does not mandate a specific type of device identifier, but a unique device identifier (“UDI”) must be placed on the device label, unless an alternative location is specified, or unless FDA has exempted the device or group of devices from the UDI system. The UDI must adequately identify the device throughout its distribution and use, and may need to include information such as the lot or serial number, if required by FDA.
It is expected to be coming out in late 2009 and later with a final rule in 2010. There are many discussions going on how to implement it, which devices come under its purview and how it can affect the different sectors.
There are very common concerns are below
1. What all devices or particular type of devices should be subject to the? Which types of devices or particular devices should be excempted?
2. What are set criteria to uniquely identify a device?
3. What should be the UDI's components? (For example, should the lot or serial number be required?)
4. Where should the UDI be placed?
5. How should the UDI be presented? Should FDA mandate a particular technology or permit different standards to be used depending on the type of device?
6. How should the UDI database be developed and maintained?
7. What is the magnitude of the problem to be addressed by the establishment of a UDI system?
Once this rule come it may change the lot of sectors using the device like HME sector along with it will help in better post marketing surveillance.
Click on the below link which contains lot of good suggestion given by America's Health Insurance Plans (AHIP) which also details about post marketing surveillance aspects.
The FDA should develop standards requiring the linking of medical device identifiers to adverse event reporting. The use of identifiers should also be required in all investigational and research studies involving medical devices. In addition, the FDA should take steps to incorporate the UPN into any databases that collect and maintain information about medical devices.
http://www.fda.gov/ohrms/dockets/dockets/06n0292/06n-0292-c000019-01-vol8.pdf
There is a conference scheduled for UDI details present in the link below.
The UID Conference is the industry gathering to help medical device manufacturers, distributors and hospitals prepare for the impending FDA UDI Rule. The FDA UDI Rule will establish a single device identification system that is consistent, unambiguous, standardized, and globally harmonized. FDA intends to issue the Final Rule in 2010
http://www.udiconference.com/
On Feb. 12, the U.S. Food and Drug Administration convened a public workshop on development of a unique device identification system for medical devices under the FDA Amendments Act of 2007, which mandates the UDI.
As part of the FDA Amendments Act of 2007 (“FDAAA”), FDAAA does not mandate a specific type of device identifier, but a unique device identifier (“UDI”) must be placed on the device label, unless an alternative location is specified, or unless FDA has exempted the device or group of devices from the UDI system. The UDI must adequately identify the device throughout its distribution and use, and may need to include information such as the lot or serial number, if required by FDA.
It is expected to be coming out in late 2009 and later with a final rule in 2010. There are many discussions going on how to implement it, which devices come under its purview and how it can affect the different sectors.
There are very common concerns are below
1. What all devices or particular type of devices should be subject to the? Which types of devices or particular devices should be excempted?
2. What are set criteria to uniquely identify a device?
3. What should be the UDI's components? (For example, should the lot or serial number be required?)
4. Where should the UDI be placed?
5. How should the UDI be presented? Should FDA mandate a particular technology or permit different standards to be used depending on the type of device?
6. How should the UDI database be developed and maintained?
7. What is the magnitude of the problem to be addressed by the establishment of a UDI system?
Once this rule come it may change the lot of sectors using the device like HME sector along with it will help in better post marketing surveillance.
Click on the below link which contains lot of good suggestion given by America's Health Insurance Plans (AHIP) which also details about post marketing surveillance aspects.
The FDA should develop standards requiring the linking of medical device identifiers to adverse event reporting. The use of identifiers should also be required in all investigational and research studies involving medical devices. In addition, the FDA should take steps to incorporate the UPN into any databases that collect and maintain information about medical devices.
http://www.fda.gov/ohrms/dockets/dockets/06n0292/06n-0292-c000019-01-vol8.pdf
There is a conference scheduled for UDI details present in the link below.
The UID Conference is the industry gathering to help medical device manufacturers, distributors and hospitals prepare for the impending FDA UDI Rule. The FDA UDI Rule will establish a single device identification system that is consistent, unambiguous, standardized, and globally harmonized. FDA intends to issue the Final Rule in 2010
http://www.udiconference.com/
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