AdvaMed wants the FDA to make a number of changes in its plan to mandate unique barcodes on all medical devices, in order to make the implementation more affordable to the industry and more practical for companies, patients and providers.
Regulators, following feedback, will implement a final unique device identification (UDI) rule likely early next year. Some estimates place the cost of implementation at about $550 million over a decade.
AdvaMed wants manufacturers of Class III devices to have two years instead of the proposed 12 months to comply with a final UDI rule, once it is issued. They also want regulators to compile a list of devices exempt from UDI direct-marketing requirements because they can't be directly marketed, such as stents and sutures. In addition, they want the FDA to make an exception for inventory manufactured before the final UDI rule effective date.
The industry trade group has said it supports the goal of using an "appropriate UDI system" but wants one that doesn't add cumbersome requirements that can lead to a lengthier approval process.
All segments of the health care industry have been submitting comments on the proposed requirements. Others are more supportive. Medical Device supplier Novation, for example, continued to back the project as a way to improve patient safety that will reduce medical errors and boost the efficiency of device recalls and reporting of adverse events with devices. A UDI program will, in part, establish a searchable database of adverse events reported by providers.
- read the release
- access the full submitted comments here