MDUFA Reauthorization: Find Out What it Means For You

The reauthorization of the Medical Device User Fee Act (MDUFA) should make some devicemaker interactions with the FDA simpler, though in at least one area it may fall short in improving industry/FDA relations. That’s the initial view of the act from Pamela Forrest, partner at the law firm King & Spalding. “There are a few things that struck me as pretty significant in a positive way for industry,” Forrest said.

Streamlining of the de novo process by which moderate risk devices with no predicate can reach the market seems like a win for industry. Under MDUFA changes, devicemakers no longer need to first file a 510(k) submission before petitioning for de novo designation. “Theoretically, there should be a noticeable time decrease in getting a de novo classification or an answer that you’re not getting one,” she said.

Similarly, she expects the requirement in the act that the FDA provide the scientific and regulatory basis for its significant decisions to applicants should create greater transparency in the agency’s activities. And, codification of the steps for appealing an agency decision also should help devicemakers better understand how to work with the agency and get quicker resolution when they disagree with significant decisions issued by the FDA.

One provision of the law that seems less likely to provide any real benefit to industry is the language that attempts to clarify the “least burdensome” standard. The FDA is directed to request that devicemakers provide only information that is “necessary” to support device clearance or approval. MDUFA adds to the law a definition of “necessary” — specifically, it defines necessary as “the minimum required information” to support clearance or approval.

“Least burdensome may be a difficult concept to clarify,” she said. “But I’m not sure that defining ‘necessary’ as ‘the minimum required information’ is going to make the least burdensome requirement any clearer than it was, or lead to any less frustration on industry’s part with data requests.”

The lack of clarity, she said, underscores the importance of engaging the FDA early in detailed discussions about what data will be needed in support of an application.

For more details about what the reauthorization of MDUFA means to your business, and how you should prepare for the changes, join Forrest and Steven Niedelman, Lead Quality System & Compliance Consultant at King & Spalding Thursday for the 90-minute webinar MDUFA 2012: First-Hand Knowledge for Medical Device Companies.