PRISYM ID, a leading provider of turn-key labeling solutions for the medical device and life sciences industries, and Reed Tech, which specialises in data capture, conversion and content management of regulatory submission data for the U.S. Food and Drug Administration (FDA), today announced that they have collaborated to provide a complete solution to better manage the submission of data to the Global Unique Device Identification Database (GUDID).
The GUDID is a publicly searchable database administered by the FDA to which medical device manufacturers must submit product information in computer-readable structured product labelling (SPL) format. The GUDID is designed to help the FDA identify product defects more quickly, prevent unnecessary product recalls and ultimately improve patient safety.
The PRISYM ID – Reed Tech end-to-end solution is designed to ease the process of medical device UDI submissions, and will allow medical device manufacturers to manage label content and submissions data all in one place. As part of the solution, PRISYM ID will work with Reed Tech to develop an interface that will allow data from the submission entry to be automatically populated onto the product label ready for printing, ensuring a single version of the data is used.
The solution aims to streamline the submission process, reducing the amount of time it takes manufacturers to enter data in order to ensure FDA UDI compliance. With the new UDI regulation for Class III devices which required compliance by 24th September 2014, and Class II to follow in 2015 and 2016, this technology is pivotal for medical device manufacturers.
Vince Postill, SVP of Business Development, PRISYM ID, commented, “This integrated solution is being developed directly in response to feedback received from customers in the medical device environment. They require a seamless, end-to-end solution that can manage the UDI data and submission and carry out the label design, printing and life cycle management of the device label. Integrating our technology with Reed Tech ensures we can offer customers the best fit for their needs.”
“We are very excited about being able to offer an end-to-end solution with PRISYM ID for the medical device industry,” stated Mark Bayer, VP of Business Development for Reed Tech. “There is a large amount of information that has to be submitted to the FDA to ensure UDI compliance, and this solution simplifies the process, as well as reduces the possibility of errors for device manufacturers.”