Head of FDA's device arm says agency aims to be first in the world to improve devices

Print 12 May 2015
Varun Saxena / FierceMedicalDevices

The head of the FDA's device arm (CDRH) acknowledged that the division is failing to live up to its vision that "patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world" because advanced devices like trans aortic valve replacements are regularly approved in Europe 5 years earlier than the U.S, but cited statistics showing that CRDH has been getting devices to market faster in an April 30 address.

"Our mission is to protect public health and to promote public health. We've done a good job on the protect side," CDRH head Dr. Jeffery Shuren said at this week's meeting of the Medical Device Manufacturers Association. "We have not done so well on the promote side, by facilitating innovation and speeding patient access to safe and effective devices."

Shuren acknowledged that the FDA approved the first TAVR 5 years after it received a CE mark, but said the agency doesn't plan to be slow to get the next wave of technologies to market: "We have now approved three early feasibility studies for transcutaneous mitral valve replacement. The first patient just got an implant last week, and the rest of the world is in exactly the same place, so we are now starting to see companies say, 'you know what we are going to do an early feasibility study here.'"

Among the steps taken speed approval times is the recent finalization of the Expedited Access Pathway for accelerated approval of critical devices. Shuren urged companies to submit investigational devices for entry into the program, saying "if this is truly breakthrough technology, if it's going to treat or diagnose a life-threatening or irreversible condition, then we should accept more uncertainty about the benefits or risks. We should work in greater collaboration with the sponsor, never at the sacrifice of our user free agreements."

The new pathway, which mimics accelerated review programs on the FDA's drug side, is the most concrete example of the device arm's general goal of making faster decisions through increased reliance on postmarket data.

"We're already relying on registry data, for example, to expand labeling indications," Shuren said, referring to the agency's often-cited use of the TVT cardiology registry to expand the recommended use of Edwards Lifesciences' ($EW) Sapien TAVR. Using registry data as the "backbone" of an enhanced postmarket surveillance system can help the agency address problems before they become big "and blow up in the newspaper," he added.

Shuren also gave a shout out to ambitious public-private efforts to develop a national postmarket medical device surveillance program, which was recently proposed by The Brookings Institution at the behest of FDA.

In addition, he pointed to statistics showing that the division is moving in the right direction after a prior spell of slow decision times. "The first decade of this century was not a good one for some of the things that were going on in the medical device program," he said.

Since 2010, the number of pending 510(k) submission is has declined by 30%, and the PMA approval rate has increased from 59% to 86%, he said.

Another focus has been on expanding the so-called presubmission process, which the agency speaks to companies on an informal basis before submissions are filled.

"We will answer your questions in writing before the meeting, and we will stand behind it," Shuren said. "In fact we now have a lot of companies who when they get our written answers, they cancel the meeting because they feel that they've already got what they need."

Another challenge facing the agency is the regulation of health information technology, such as mobile health apps. Shuren pointed to a number of guidances issued in the arena, which have moved the agency in a "hands off" direction. "We used to regulate all the technology that receives, transfers, stores or displays data for medical devices. Years ago it was Class III. In 2011 we made it Class I. This year we made it class zero. We don't regulate it anymore," he said.

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