How to Classify Medical Devices for FDA’s UDI Mandate

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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 for 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 device 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.

Classify a Medical Device Manually

While it may be time-consuming, it is certainly possible to manually classify a medical device. This is a much more detailed process that should leave anyone with a great deal more insight into how medical devices are classified by the U.S. Food and Drug Administration.
No matter how you decide to proceed, you’ll find a great starting point at the Overview of Device Regulation. Here you’ll find everything you need to become compliant with the FDA’s latest regulations for the medical device industry.
IDAutomation provides a variety of barcode fonts and software solutions designed to allow barcode generation in a full range of applications and environments. Our products are fully compatible with the FDA’s newest standards for medical devices.
To verify the correct encoding of non-printable ASCII characters used for UDI such as RS, GS, and EOT, IDAutomation recommends testing the result with the Barcode Decoder App because it reveals these characters in the result.
Published on: Dec 27, 2013