AdvaMed Statement on Final Unique Device Identification Rule (AdvaMed)
FDA.gov, AdvaMed statement, UDI Resource from FDA
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 manufact...
