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.
Despite the regulations coming into force for Class III devices from September 2014*, many of the industry’s smaller players are still finding the new regulations challenging. Conversely, size has not meant that the industry’s biggest organizations have been immune from product recall – with some of the sector’s largest multinationals featuring prominently on the 2013 FDA Enforcement Report. The implementation of UDI is, therefore, an industry-wide challenge. And if companies have not yet addressed it comprehensively and holistically, they need to act quickly.
* Exceptions are permissible