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...