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.
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.
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).
Implantable medical devices in the supply chain haven't always received the attention they deserve from authorities.
The World Economic Forum wants to help supply chain businesses address risk management.
View webcast >> Join Loftware and Jay Crowley, FDA Senior Advisor for Patient Safety, to discuss upcoming FDA and Unique Device Identification (UDI) requirements and their overall impact on your business.
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.
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.
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.
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.
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.
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...