May 18, 2014
From the Healthcare & Life Sciences Institute
Regulatory mandates in the United States are changing the way medical device manufacturers identify and provide data about their products.
Regulations have been enacted and are phasing in over the next three years in an effort to improve device safety, facilitate access to device attributes and provide device attribute data that promotes the device’s use. Similar to the pharmaceutical industry and serializations regulations, the medical device industry faces challenges to promote patient safety.
However, the challenges faced by medical device manufacturers are not related to counterfeiting or product adulteration, but rather are associated with the complexity and risk inherent in these important, life-saving and/or life-changing products.
In addition, transformation is occurring within the area of post-market surveillance of medical devices, specifically adverse event reporting, device registration, and recording and accounting of transactional data.
This document provides an overview of the U.S. FDA Unique Device Identification Ruling and the cross-functional challenges organizations will face as they seek to achieve UDI compliance.