A few years ago, the FDA instituted new medical device product labeling and registration requirements akin to those mandated in the pharmaceutical sector. It is called UDI – for unique device identification. The new requirements included standardization of a product numbering system and encoding of that number along with other information in both HRC (human readable) and bar code formats. It was designed to make products more traceable.
The law was to be phased in over a number of years with the most complex medical devices (Class III) beginning in 2014 and the least “regulated” (Class I) in 2018. Though we understand the need for much of the regulations imposed on medical devices, this one felt very misguided (most medical devices are already traced pretty extensively via the Medical Device Act, and the new law overlooks the hospital and physician link in the supply chain) – but we moved ahead.
My regulatory department took a very proactive approach and I am proud to say we not only met the deadline for Class II devices, we are two years ahead of the curve on Class I. (ADC does not manufacture any Class III devices.) Today, we are fully, 100% compliant. Additionally, although NOT part of the mandate, we modified our ERP system (the computer system that powers our business) to capture the complex bar codes that often contain product, lot, serial, and expiration data) at time of shipment, which we can then transmit to our distributors if they want that information.
With a reported 85% of medical device companies failing to meet the September deadline, I am proud of my team and the thousands of man-hours they all put into the project. We don’t really think it will make our products any better -- but they’re already pretty darn terrific, if I do say so myself!