On September 24, 2013, the Food and Drug Administration (FDA) passed the final rule for the Unique Device Identification System. By ushering in a new era of supply chain harmonization, the rule is aimed at ultimately enhancing patient safety and operational efficiencies within the entire healthcare industry. It includes three major requirements dental implant machine.
First, every medical device must be assigned a unique device identifier (UDI), and the label or package of all medical devices must include that device’s UDI in both plain text and in a format that uses automatic identification and data capture (AIDC) technology or, in other words, a barcode.
Second, the labeler or brand owner of the device must submit product information about it to the FDA’s Global Unique Device Identification Database (GUDID). Accessible online and administered by the FDA, the GUDID serves as a reference catalog for every device with an identifier.
Third, the actual device will need to be directly marked with a UDI if it is intended to be used more than once and reprocessed before each use. The FDA has allowed for a few exceptions for certain products for each of these requirements, but, for the most part, the final rule applies to the vast majority of classified medical devices.
What This Means to the Dental Profession
The FDA has issued compliance dates for medical devices to meet these requirements in a phased approach based on device risk. Class III medical devices, which include the highest-risk medical devices, had a compliance date of September 24, 2014. This was followed by a compliance date of September 24, 2015, for implantable, life-sustaining, and life-supporting devices.
Class II medical devices, which include a broad spectrum of medium-risk devices from powered wheelchairs to acupuncture needles, must be compliant by September 24 this year. Class I medical devices, which represent the lowest-risk category of products, have a compliance date of September 24, 2018.
To the FDA, the channel or market that a medical device flows through is not relevant. The FDA UDI rule applies to any medical device in any market in the United States. So, medical devices manufactured and sold in the dental industry must meet the same compliance dates and requirements as those in the traditional healthcare industry dental equipment.
Therefore, the impact on manufacturers or labelers of classified medical devices, even in the dental market, is clear. Any products manufactured and placed into commercial distribution on or after their compliance date must meet the FDA UDI final rule requirement. Many dental device manufacturers are well on their way to implementing these requirements for their products turbine air compressor.