Dive Brief:
- FDA device center chief Jeff Shuren said Wednesday that the likely reality that Congress will maintain current funding levels instead of boosting agency funding will have an adverse effect on the agency's ability to launch the Center of Excellence for Digital Health as outlined in President Donald Trump's fiscal year 2019 proposed budget.
- The center seeks to address what FDA Commissioner Scott Gottlieb characterizes as underinvestment in the U.S. digital technology industry "due to uncertainty over both the high cost of regulatory burdens and uncertainty of adequate patient safeguards."
- The resources, if appropriated, would allow the FDA to advance its pre-certification model for digital health, explore building a way to evaluate third-party certifiers of digital technologies under a pre-certification program, create a new cybersecurity unit to help oversee software-based devices and investment in other regulatory tools, Gottlieb wrote Wednesday.
Dive Insight:
Although the FDA receives medical device user fees from industry that can be used to bring new technologies to the market, additional resources to launch a Center of Excellence for Digital Health would allow the agency to be more proactive, Shuren told MedTech Dive on the sidelines of MedTech Conference in Philadelphia.
"The Center of Excellence would require additional resources to build out that capability. What we're funded for under [the user fee law known as] MDUFA is to be able to be more reactive on the technologies that come through. But if we want to be proactive and truly serve as a resource in our ecosystem for advancing digital health technologies, then we need to have the capabilities to do so."
Shuren noted that while the House was supportive of the additional funding, there was not support in the Senate. With a Continuing Resolution funding the government at current levels likely, some of the items FDA wants to invest in may have to wait until down the road.
In February, Gottlieb said some of the $400 million in additional funding FDA was seeking would be used to bolster the National Evaluation System for health Technology to better utilize real-world evidence to evaluate pre- and post-market safety of medical devices.
"We have the funding from user fees that is going into NEST and we are still going to move forward for [NEST] version 1.0 to be ready for 2019. The funding that we have sought in the president's budget proposal is to build out additional capabilities that would take NEST to the next level," Shuren said.
He added: "For example, the active surveillance capabilities, there are investments that would go to the Women's Health Technologies Coordinated Registry Network, those are things we discussed in our Medical Device Safety Action Plan."
Shuren warned that as the global medical device market matures and the U.S. continues to harmonize internationally, investment is critical to maintain FDA's status as the gold standard.
"This is really a big question for the ecosystem. If we care a lot of about it, are we putting the investments in there to make it happen? That will allow us to remain the gold standard. I do think we have to have a change in mind set with this, because there are other parts of the world that would like to be the gold standard and they are not going to stop, and we are not going to undercut them, we don't do that to other countries, we see them as partners."
