The Food & Drug Administration’s user fee program collects payments from medical device makers when they submit their devices for review by the federal watchdog agency. Yesterday, MassDevice took a look at competing claims from the medical device industry, the FDA and other stakeholders over the effectiveness of the program. Today we look deeper into whether the program is adequately meeting its own goals.

Another commitment the FDA made in exchange for receiving user fees from industry was to expedite its production of guidance documents to provide industry with a "roadmap" of how to bring a product from development to clearance for sale.

"Having that roadmap, that document that says that from FDA’s perspective, here’s what we need, that gives us a lot of certainty and predictability, which are two of the things that our companies care about most," noted Medical Imaging and Technology Alliance executive director David Fisher.

While the agency has produced a number of guidance documents related to medical devices in recent years, "that guidance development has moved along just like it had before in the previous five years and that’s fine, but I think from our perspective we really hope for more," he said.

And in some cases, guidance recently released by FDA is actually creating confusion rather than clarity among companies, Fisher noted. For example, he pointed to a recently published guidance document industry had specifically requested during the 2007 MDUFA re-authorization, related to contrast agents, chemicals used in some imaging procedures to enhance the picture the physician gets.

"Rather than providing predictability and certainty and a roadmap for our companies, it’s actually confused our companies and has made things actually more challenging in terms of getting products cleared for market," Fisher said. "And it appears to us that it actually may have frozen the clearance process for products that have procedures associated with them that include contrast."

In response to the recent guidance, confused companies have begun to de-feature products, or to remove technologies from them, in order to get them cleared for sale, Fisher said. Often, the technologies that are now being taken out of machines because they are associated with contrast agents are not new technologies, but ones cleared five years ago, he added.

Current FDA leadership is not to blame

Medical Device Manufacturers Assn. president and CEO Mark Leahy acknowledged that it’s unfair to blame current FDA leadership for problems within the medical device user fee program. Additional user fees from industry and some review process improvements actually led to "significant improvements in review times from 2002 to 2005," he said.

"People are saying these issues are new within the last 18 months, [but] if you look at the metrics of performance, at least quantitative performance, I think 2005 was kind of the high-water mark … and since then it’s deteriorated a bit in some areas," he said.

Leahy pointed to a 2006 FDA-commissioned report, which found "almost 70 percent of responding device manufacturers perceived MDUFMA goals have not resulted in meaningful results in either predictability or timeliness of device review." If the same question were to be posed now, that number "unfortunately would be a bit higher," he said.

"Where it currently stands right now, I think our members would be hard pressed to support the continuation of this program, but I am confident … we’ll be able to work together … to develop a program with reasonable fees, enhanced performance [and] greater predictability," Leahy said.