Labeling / Medical Devices / Regulatory and Compliance / Serialization / Standardization / Supply Chain
FDA publishes amendments to original UDI proposal
The U.S. Food and Drug Administration (FDA) recently announced that it is amending the implementation timeline associated with its previously proposed unique device identification (UDI) rule. The updated proposal was published in the Federal Register on November 19.
FDA unveils device capable of detecting drugs with counterfeit, tampered-with labeling
On September 10, the U.S. Food and Drug Administration (FDA) announced that it had begun deploying a new tool in its efforts to prevent counterfeit drugs and medical devices from entering the country.
FDA to host conference focused on UDI requirement for medical devices
The U.S. Food and Drug Administration (FDA) recently released a proposal for a new rule that would require most medical devices distributed in the U.S. to be marked with a unique device identifier (UDI).
Senators introduce bill to improve medical device tracking
Implantable medical devices in the supply chain haven't always received the attention they deserve from authorities.
Protecting the supply chain starts with you
The World Economic Forum wants to help supply chain businesses address risk management.
Consumer’s group requests better label compliance on medical devices
Label tracking and traceability continues to be a topic of concern in the medical device manufacturing industry, and now a consumer group has asked Congress to step in on establishing improved label compliance for this sector.
New USP guidelines for pharmaceuticals, medical devices on tap for 2012
A national nonprofit says it will release a set of guidelines next year to establish best practices for standardization and to combat counterfeit labeling in these industries.
FDA encouraging comments on medical device label compliance
Tthe FDA wants healthcare providers to rate current labeling based on its usefulness (particularly when it pertains to device instructions), coherence, organization and how often they are actually able to follow the instructions printed on the label.
FDA to host conference on unique device identification systems
With oversight managed by the Food and Drug Administration (FDA), the UDI database will, conceptually, increase label tracking and traceability in the medical device manufacturing industry by requiring product makers to record unique identifiers on each device's label.
Counterfeit surgical mesh at the heart of lawsuit
Earlier this year, the Food and Drug Administration (FDA) issued a recall and announced an investigation into what it identified as a case of counterfeit surgical mesh being distributed to physicians and hospitals around the country.
Medical Device Barcode and RFID Tips that can Streamline Joint Commission Visits
Recently, MD Publishing posted an excellent article entitled, ‘Cover Story: Strategies For Success,’ which is all about the ways in which clinical engineering professionals can and should track and manage medical devices and why this is important. The article not only spotlights the requirements of The Joint Commission, which accredits and certifies more than 18,000 health care...
GHS and Regulatory Labeling Challenges in the New Era 
