Device Labeling Provision Comes Under FireDevice Labeling Provision Comes Under Fire

Originally Published MDDI February 2004

NEWSTRENDS

Erik Swain

Industry is encouraging the repeal of a section of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) that requires all devices to bear the name of the manufacturer. FDA says that repeal is not likely to happen, but the agency will implement an exemption process. 

Section 301 of the act elicited strong criticism at the MDUFMA stakeholders meeting, held December 3, 2003, in Gaithersburg, MD. (For more about this meeting, see “From the Editors,” p. 14, and “Washington Wrap-Up,” p. 40.) 

Associations representing medical device manufacturers had lobbied for a provision requiring reprocessed single-use devices to be labeled with the name of the reprocessor. That way, if a problem with a device occurred, the reprocessor would be contacted instead of the original manufacturer. However, Congress decided to expand the provision to require all devices to be labeled with the manufacturer's or reprocessor's name. 

“Section 301 requires the device to be labeled so we know who is the responsible manufacturer, but FDA can waive it if it's not feasible or if it compromises safety or effectiveness,” said Casper Uldricks of CDRH's Office of Compliance. “The Senate granted us 18 more months to implement this section, but we still need to think about how we are going to work with this. We are trying to figure out an easier way that relieves the burden a little bit. How are we going to grant waivers? What will be the criteria for determining if it's not feasible? Cost? Risk? Brand confusion?” 

Mark Leahey, executive director of the Medical Device Manufacturers Association (MDMA; Washington, DC), called the provision “unnecessarily broad and unworkable for FDA. This was intended to close gaps in [adverse event] reports, so we could identify reprocessed versions of single-use devices. Extending it to OEMs would be an enormous cost that could stifle or kill innovation. The cost of applying it would far outweigh the benefit, especially given the original intent.”
 
The Association of Medical Device Reprocessors (AMDR; Washington, DC) says the broadened provision is fair, however. “Congress's intent was clear, and it's reflected in the legislative history,” said Pamela Furman, executive director. “It places a significant burden on small manufacturers and reprocessors alike. Congress intended that it would apply to all, and we urge FDA to reject suggestions otherwise.”

Robert O'Holla, vice president, regulatory affairs of Johnson & Johnson's Corporate Medical Devices and Diagnostic Group (New Brunswick, NJ), countered that “when broadened, this section became impractical and unnecessary.”

“Not all devices can or should be labeled,” said O'Holla, who spoke on behalf of AdvaMed (Washington, DC). “Examples include screws, implants, and surgical gloves. We encourage FDA to grant waivers as broadly as possible and to seek the appropriate legislative fix.”

FDA officials said, however, that some members of Congress believe that broadening the requirement is an appropriate safety measure, so industry should not count on a repeal. 

Instead, said Linda Kahan, CDRH's deputy director, “since the law is here, it will be useful to us if industry's docket comments relate to the practical issues. If there is a category that you want to tell us should not be labeled, that's what we need to hear. And include practical tips too.”


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