Devicemakers Agree to Nearly $1 Billion in Fees Under MDUFA IV

The FDA and the medical device industry have agreed on the terms for a new medical device reauthorization package that would allow the agency to collect $999.5 million in user fees over the next five years.

Effective Oct. 1, the draft agreement marks the fourth reauthorization of the medical device user fee program. Details will be published in the next few weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.

The MDUFA IV agreement does not change user fees announced for fiscal year 2017 that were released in late July. The user fee plan would begin in fiscal 2018.

The funding under MDUFA IV will go toward hiring additional full-time staff at the FDA to shorten device review times and improve efficiency. Other efforts include establishing a program to collect real-world evidence from different sources, such as registries, electronic health records, and other digital sources; a third-party premarket review program; and development of a submission and tracking portal.

AdvaMed said the agreement “has the potential to be a game changer to improve the efficiency and predictability of the agency’s review process.

“The legislation includes a series of strong, measureable performance goals and additional resources that should help reverse the decline in performance FDA has experienced in recent years,” the association said in a statement.

The agreement also includes more opportunities for interactions between FDA and sponsors before and during the review process, and an independent outside review of the agency’s management of the review process, the association added.

AdvaMed highlighted the following performance goals of the new agreement, which include:

• Significant improvements for total review time goals, which will lower the total time goal for 510(k)s and PMAs to historical norms;
• Greater accountability through two independent analyses of FDA’s management of the review process — one at the beginning and one at the end of the MDUFA IV timeline — and implementation by the agency of a quality system management approach to the device review process; and
• Further process enhancements to increase the consistency and timeliness of the review process. These include FDA commitments to provide feedback to companies at least five days prior to a pre-submission meeting; a requirement to document the rationale for issuing a deficiency letter; implementation of a standards conformity assessment program; and a pilot to assess the effectiveness of real-world evidence to support premarket activities.

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