How to Classify Medical Devices for FDA’s UDI Mandate
Back in September, the Food and Drug Administration announced new labeling requirements for medical devices. Although many manufacturers and other businesses in the medical devices field will have some work to do in preparation of the mandates, it is thought that the inclusion of a unique device identifier (UDI) for each product will be a significant benefit in terms of improving patient safety, maintaining control of inventory and being able to respond quickly to recalls or other problems in the market.
The FDA has established classifications for approximately 1,700 different types of medical devices separated out into 16 specific categories. Further, each devices is assigned to one of three special classes as determined by critical factors including necessary safety measures, effectiveness and intended use. This class assignment determines things like the types of applications required, exemptions, fees and more.So, where does your device fit in? Here are a couple of ways you can find out:
Medical Device Product Classification Database
This is most likely going to be the quickest and easiest way to determine your product’s classification. The Product Code Classification Database contains device names and unique product identifier codes assigned to generic device categories. Just enter some key information such as Device, Product Code, Regulation Number and Device Class to locate the correct product classification for your medical device.