The leader of improving relations between the FDA and the med tech industry
Name: Jeffrey Shuren
Title: Director of the FDA's Center for Devices and Radiological Health
When Dr. Jeffrey Shuren took over the FDA's medical device arm (CDRH) at the beginning of 2010, overly tight regulations of devices and investigational clinical trials had "decimated" the med tech industry, in the words of NEA partner Dr. Justin Klein.
Shuren has succeeded in winning the trust and respect of the device world through his words, and more importantly, his actions. Initiatives like the Expedited Access Pathway for "breakthrough" devices are beginning to show results. With the acceptance of Avita Medical's ReCell Autologous Cell Harvesting Device for treating burns, the number of devices in the accelerated review programs stands at 6 by FierceMedicalDevices' count.
And the emphasis on speed extends to broad-based measures well. The agency just boasted that it approved PMA applications for high-risk innovative devices at a record pace during the first three months of 2016, taking an average of 209 days to arrive at an approval (or rejection) decision. That's down from 252 days in 2015 and 352 days in 2009. In addition, the agency reviewed so-called Investigational Device Exemptions, which enable a device to enter premarket trials in the U.S., in an average of 30 days in 2015, compared to 442 days in 2011.
But Shuren is still far from achieving his goal of making the FDA the first agency in the world to approve devices. It's still regularly beat by Europe's CE-mark system, often by a year or more (though it's worth noting that Europe has long been trying to tighten its device regulations, and that achieving a CE mark on the continent is often followed by lots of additional studies prior to commercialization).
Using the tools at his disposal, including the issuance of draft guidance, Shuren is aiming to make the U.S. regulatory system more like Europe's by shifting a greater share of the regulatory effort from premarket testing to postmarket monitoring. Such an approach is more in line with the device industry's iterative nature and would capture the effects or "real world" challenges that are often not a factor in closely monitored clinical trials.
The ongoing implementation of the Unique Device Identification (UDI) system is critical to improving real-world surveillance. Shuren has set a goal of gaining access to 100 million electronic patient records with device identifiers by the end of 2017.
One notable exception to his industry-friendly record is CDRH's issuance of a draft guidance that would regulate the lab-developed test (LDT) segment of the diagnostics industry. LDT providers have threatened to sue the FDA via the American Clinical Laboratory Association (ACLA). It took years for the FDA to issue its long-planned draft guidance, and the final guidance, which would begin the reform's implementation phase, was promised last year.
Besides UDI implementation and diagnostics industry regulation, Shuren faces two congressional battles that will certainly test the limits of his influence and diplomatic skill. First is the reauthorization of the Medical Device User Fee Authorization Act.
Will industry's newfound respect for the FDA result in med tech companies agreeing to pay an additional $500 million in user fees to finance the device arm's various initiatives?
And don't forget about the 21st Century Cures Act, a bill that would overhaul FDA's regulation of the device (and drug) sector in a largely pro-industry manner if it passes the Senate and leave Shuren with a bunch of new congressional mandates to meet.
Shuren will surely help to determine the bill's contents on the device side, as will his new boss, just-confirmed FDA commissioner Dr. Robert Califf.
-- Varun Saxena (email | Twitter)
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