The Food & Drug Administration (FDA) has announced the final ruling that will require medical device manufacturers to label each unique medical device distributed in the U.S. with a UDI “Unique Device Identifier” label. Are you prepared for the FDA’s medical device labeling regulations?
The new regulation, under rule number FDA-2011-N-0090, proposes the development of a public database. This database will house information about each unique device and be made available for regulators, physicians and other interested parties to for the proposed safety related information for Class II and Class III medical devices.
Alongside the challenges for manufacturers to comply with the new standards, are obstacles associated with label design and material compliance. This ruling requires the device data be displayed on the label in both plain text as well as AIDC (Automated Identification and Data Capture) format that can be read by scanners and other label reading technologies.
External medical device classifications apply only to medical devices that are intended for use outside of the human body. These regulations do not affect devices that are planted internally. They are defined and set apart by the FDA as devices only and do not reference pharmaceuticals or drugs.
External medical devices are classified into three groups.
Class I
Class I medical devices require the least amount of regulation. The devices are categorized as those devices that are not intended to sustain or support life. Examples of Class I medical devices are cotton swaps, tongue depressors bandages, etc. These products would be labeled in batches, generally found on each box. They would not requie a UDI label.
Class II
Class II medical devices that are intended for products whose features support health and well-being, examples of these products are wheelchairs, hospital beds and infusion devices. These devices are subject to more rigorous identification practices, pre-market notification and post-market monitoring. These devices must be labeled individually and in some instances, various internal parts must also be labeled. Labeling of such Class II medical devices goes beyond Class I requirements of batch labeling.
Class III
Class III external medical devices are those that support or sustain human life. The devices are subject to extensive post-market review to assure public safety. Examples of Class III medical devices include generators, defibrillators and diagnostic test equipment. These devices will most likely see not only individual part identification but also individual part marking on components.
The benefits of the new regulation will allow the FDA and other interested parties to review issues of safety and compliance for each individual product or model. In addition, they can in turn issue recalls or adjust purchasing based on this information. The newly approved standard, requires medical device manufacturers to place a label on each device in each batch that indicates, in plain text format and automated Information formats the Make, Manufacturer and Lot Number of each device.
The FDA database, the Global Unique Device Identification Database, (GUDID) is in place to eliminate misuse of medical device products, track adverse information and provide real-time solutions for organizations and affiliates working with these devices daily.
ImageTek is ahead of the compliance curve and stocks MedTek® UL recognized materials to meet this new requirement. Our materials offer thermal transfer topcoats with acrylic adhesive that will stand up to many of the harsh environments found in medical facilities. In addition to UL standards found in the new regulations there are chemical resistant standards. Approved materials for unique identification labels of medical devices must be resistant to many of the chemicals they will come in contact with in cleaning and sterilization. ImageTek MedTek® UL approved materials comply with FDA ‘s 21CFAR Part 801 labeling guidelines in accordance with UL969 for medical device applications. They also comply with IEC 60601-1 3rd Edition (7/1/2013) marking and durability rub tests. Our LVS 7500® Verification System will scan your labels prior to shipping and deliver a compliance report to you with your labels to ensure quality and continued improvement traceability.
ImageTek is here to help you understand the regulations and be prepared for the changes in your identification processes. For more information about the proposed changes please contact Bethaney Lanou, Technical Procurement Associate at (866) 403-5223 or email blanou@pcmanufacturing.com.
