The company announced that its products are already compliant with the FDA’s Unique Device Identification System ahead of the agency’s September 24 deadline.
In 2007, the U.S. Food and Drug Administration (FDA) set out a number of requirements to improve transparency of medical device product information for consumers, including resellers, distributors, clinicians, and patients, setting up the Unique Device Identification (UDI) System. The FDA Amendments Act of 2007 mandated that medical device manufacturers be in full compliance with UDI by September 24, 2020.
With the deadline quickly approaching, American Orthodontics, as a manufacturer of orthodontic products classified as medical devices, released a statement highlighting the fact that they were compliant with the UDI System months in advance. As the company points out, compliance provides customers with the assurance that all safety risks are carefully considered and mitigated to their lowest possible levels, in both design and manufacturing.
The FDA established UDI to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. It was signed into law on September 27, 2007, as part of the Food and Drug Administration Amendments Act of 2007.
“American Orthodontics focuses on being the best at taking care of our customers,” said CEO Randy Benz. “We spend considerable time and effort on all regulatory compliance as AO products have gone through the rigor of registering products with regulatory authorities in over 75 different countries. This ensures AO products are continually in full compliance with regulatory standards, even as global medical device requirements evolve.”
Medical devices are classified in three categories. Class I devices include items such as molar bands, while Class II devices include brackets and fixed and functional devices such as Powerscope. Class III medical devices include orthodontic items such as TADs or implants. Class III devices were required to be compliant as of September of 2016 and Class II requirements had to be met by September of 2018.
As a part of UDI, product packaging includes a comprehensive labeling system. All product labels must include a barcode and other important traceability information, such as an identification number, lot number, and in some cases an expiration date. According to American Orthodontics, orthodontists who use UDI compliant devices benefit from full traceability of unopened product sequentially back to the raw material stage in case any questions arise. Additional warning symbols are present for increased safety and functionality. UDI labels include a scannable barcode, providing a simple method of inventory control, minimizing the potential for human error. With the UDI System, orthodontic offices reportedly can quickly and easily check if items in their facilities are included in a product quality notification.
UDI also mandates medical device manufacturers to make a submission to the FDA’s Global Unique Device Identification Database (GUDID). This searchable public web database, https://accessgudid.nlm.nih.gov, provides product information for public use.