Challenges for Manufacturers
Explore this issue:April 2013
While the FDA has pushed the rule as a boon, Buthusiem said the downside encompasses the “time, effort and expense” of crafting UDIs. For some devices, it could mean more expensive labeling or manufacturing processes. The Medical Device Manufacturers Association (MDMA) agrees and has continued to lobby for flexibility in the rule. Buthusiem said that because the rule rolls out in phases for seven years after publication of the final rule this spring, there is time to continue those discussions.
“This transition will require the medical technology industry to spend significant resources to comply,” the MDMA wrote to the FDA last fall. “With smaller companies facing a looming medical device tax, increased user fees and a reduction in venture capital investment, allowing as much flexibility and time to comply is critical.”