Committee holds optimistic hearing on medical device fees

The Energy and Commerce Subcommittee on Health held a hearing on March 28, 2017, to consider the reauthorization of the FDA Medical Device User Fee Amendments (MDUFA). The MDUFA, set to expire in September 2017, authorizes the FDA to collect fees from the medical device industry in order to support product reviews. The MDUFA was last reauthorized in 2012 and must be reauthorized every five years. In his opening statement, Subcommittee Chairman Michael Burgess (R-Texas) noted that approving the reauthorization would “increase efficiency at the FDA and ensure that American patients benefit from advances in biomedical technology and innovation as soon as safely possible.”

MDUFA IV

The agreement under consideration (MDUFA IV) is an extension of previous MDUFA process improvements. The agreement builds on existing federal law, streamlines the development and review of medical devices, and would average approximately $200 million in negotiated fees for the FDA per year.

Approval time

Jeffery Shuren, Director of the FDA Center for Devices and Radiological Health, testified as to the previous success of the MDUFA, noting that between 2009 and 2015, the time it took to reach a decision on a premarket approval application (PMA) decreased 35 percent. Additionally, between 2010 and 2015, the time it took to reach a decision on a 510(k) decreased 11 percent. Shuren suggested that further progress can be made. Robert Kieval, a Board Member of the Medical Device Manufacturers Association (MDMA), testified that the most recent agreement includes updated decision time targets for 510(k)s and PMAs, and, for the first time, review time goals for de novo technologies and pre-submissions. Specifically, Patrick Daly of Cohera Medical testified the MDUFA IV aims to bring decision time for PMAs from 385 days to 290 days and bring decision times for 510(k)s from 124 days to 108 days.

Recommendations

Diane Wurzburger a regulatory affairs executive at GE Healthcare, testified on behalf of the Medical Imaging and Technology Alliance (MITA). She noted that the medical imaging community is looking for more predictability, consistency, transparency and timeliness in the premarket device review process. Specifically, she said manufacturers are interested in shortening 510(k) approval time, obtaining performance metrics for the pre-submission process, and third-party independent assessments. She also reiterated previous comments that the MDUFA advances shared goals between the FDA and the medical device industry.