FDA Starts MDUFA Cycle By Gathering Feedback

Top FDA officials last week listened to stakeholder feedback on what has worked well and what can be improved in the Medical Device User Fee Amendments.

“I do see clear signals that this program appears to have worked,” said Acting FDA Commissioner Stephen Ostroff, adding “it’s clear more can be done and should be done.”

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, pointed to some of the successes under MDUFA, including a 30 percent decrease in the number of pending 510(k) submissions since 2010 and a growing number of presubmission meetings with the agency to address potential problems and concerns early in the process. “It’s clearly very popular with industry,” he said.

Stakeholder Input

Held July 13 at the agency’s White Oak campus in Silver Spring, Md., the meeting featured representatives from the agency, industry, academia, healthcare and patient and consumer groups and marks the first step in the development of MDUFA IV.

Participants identified improving FDA reviewer training and enhancing postmarket data collection as two key areas upon which CDRH should focus. Megan Hayes, director of regulatory standards strategy at the Medical Imaging & Technology Alliance, said “some troubling trends remain in the FDA review process,” including the burdens created by answering reviewer requests for more information.

“The medical imaging industry is extremely important to healthcare,” she said, emphasizing that many complex technologies come to market at a result of advancements in the field. It is essential to get new hires up to speed to prevent inconsistencies in reviews.

Emphasizing that she has seen significant progress — including improved interactions between industry and FDA staff and useful quarterly meetings with the agency — Janet Trunzo, trade group AdvaMed senior executive vice president, agreed that regulatory submission process was reviewer-dependent. While acknowledging that review times for applications have improved, she sees the assessment of combination products as one area in which progress is needed.

Looking to the Postmarket

Josh Rising, director of healthcare at the Pew Charitable Trusts, was among those who stressed the need for robust postmarket data collection. He pointed to the pharmaceutical industry, which uses its user fees on postmarket surveillance and patient-reported information.

Speaking on behalf of the American College of Cardiology, Frederic Resnic said postmarket surveillance is underdeveloped. He noted that CDRH faces an uphill battle retaining clinicians and other content experts to help in this regard. He offered the expertise of professional societies, such as ACC, to help make advancements in this area.

Greg Daniel, fellow and manager for evidence development and biomedical innovation at the Brookings Institution, highlighted areas in which progress can be made in conjunction with MDUFA IV to enhance postmarket data collection. These include interoperability, unique device identification and the collection of clinically meaningful data.

Timeline

The public meeting kicks off a 30-day review period during which stakeholders may offer their input to questions in a Federal Register notice on the MDUFA meeting, said Malcolm Bertoni, the associate commissioner for planning and director of the office of planning in the Office of the Commissioner. Starting in September and lasting one year, the agency will hold monthly meetings with members of industry with an eye toward developing a draft set of MDUFA recommendations.

The agency will publish the draft recommendations for stakeholder feedback, and follow that with another public meeting. Ultimately, the FDA aims to pass a finalized version by Jan. 15, 2017, so congressional committees may work on it and pass it before MDUFA III expires on Sept. 30, 2017.

Ostroff noted that while efforts to pass 21st Century Cures and the upcoming presidential election could make the atmosphere spirited, he has full confidence MDUFA IV will benefit industry. — Elizabeth Hollis