Manufacturers have 1 year to implement a Unique Device Identification system for all Class III devices
Janet Trunzo, senior executive vice president, technology and regulatory affairs, for the Advanced Medical Technology Association (AdvaMed), issued the following statement in response to FDA’s release of a final rule establishing a unique device identification (UDI) system for medical devices:
“While we are still reviewing all the details of the final rule, AdvaMed commends FDA for addressing many of the concerns industry raised in the proposed rule. We have long supported a UDI system for medical devices that, if appropriately implemented, holds the promise of more accurate and useful post-market surveillance and more rapid medical technology improvements. And this rule is a good step toward achieving that goal.
“We are pleased that FDA recognizes the difficulty and limited benefit of direct marking of implants and has eliminated this requirement. Similarly, we commend FDA for concluding that multiple single-use devices within multi-packs only need the UDI on the multi-pack and not the individual device.
“We are encouraged that FDA understands that many manufacturers will still have extensive inventories of product when the UDI rule goes into effect and will allow an additional three years for inventories to be depleted. Also, in line with industry recommendations, FDA acknowledges that one year may not be enough time to implement a UDI system for all Class III devices and will allow firms to petition to extend the implementation period based on public health and supply disruption issues.
“Finally, while FDA recognizes the ISO date format is more appropriate than their proposed American format, we are puzzled that the final rule includes the day of the month for expiration dates when expiration date testing generally does not include the day of the month.
“Implementation of a UDI system will be costly and challenging endeavor, affecting all medical technology manufacturers. It is imperative that it is implemented correctly the first time, and that its ongoing use is practical, economical, and of value to patients, health care providers, industry and FDA.
“We are committed to working with FDA and other stakeholders to move forward in implementing this final rule to establish an effective UDI system that takes into account the diversity of medical devices and provides information useful to understanding their post-market performance.”