WHAT IS IT?
The Food and Drug Administration (FDA) governs health and human services in the United States. It protects public health by enforcing safety and security regulations for drugs, vaccines, and other biological products and medical equipment. Read More
Data shows that more than half of all FDA recalls of medical devices have been caused by packaging and/or labeling errors. What is the best way to survive an FDA recall? Make sure you are compliant not only by fixing the recall issue, but preparing for the future.
Ignoring the warning signs of non-compliance is no longer an option
Data shows that more than half of all FDA recalls of medical devices since Q1 2014 have been caused by packaging and/or labeling error. One of the most high profile recent examples was the Class I recall of a Peripheral Infusion System, where major mislabeling risked the incorrect use of the product by physicians and raised the potential for serious patient injury or death.
In a recent survey, 43% of responders were not confident or were unsure as to whether their current labeling solution would do everything required beyond 2015. With regulations such as 21 CFR Part 11 to comply to and others coming to fruition including FDA UDI, medical device manufacturers whether large or small need to be change. Read More
The implications of product recall are well understood, and they serve as an operational driver for a change of approach. But the latest FDA announcement that its online Global Unique Device Identification Database, AccessGUDID, is now available to the public brings the labeling of medical devices under unprecedented levels of scrutiny – with ramifications not only for manufacturers but also throughout the entire supply chain. Read More