Regulatory Focus™ > News Articles > MDUFA IV: Negotiations Step Forward, But Gaps Remain

MDUFA IV: Negotiations Step Forward, But Gaps Remain

Posted 26 May 2016 | By Michael Mezher 

MDUFA IV: Negotiations Step Forward, But Gaps Remain

The medical device industry is calling for the US Food and Drug Administration (FDA) to add 91 new employees as part of the latest talks over the next version of the Medical Device User Fee Act (MDUFA), though industry also says it needs more information on several recent FDA proposals.

FDA, meanwhile, says industry's proposal, while a step in the right direction, won't add the staff necessary for the agency to meet its performance goals and does not help with several other critical areas, according to the latest MDUFA meeting minutes.

The industry groups, headed by the Advanced Medical Technology Association (AdvaMed), Medical Device Manufacturers Association (MDMA) and the Medical Imaging & Technology Association (MITA) pitched their proposal to FDA on 27 April 2016, two days after hearing FDA's latest proposal that would create a new user fee for reviewing applications using real-world evidence (RWE).

Industry Proposal

In total, the industry proposal would provide FDA with $680 million (plus inflation) to meet FDA's current performance goals, plus an additional $131 million to support the 91 new employees.

The bulk of the industry proposal involves adding to FDA's workforce to "create efficiencies" within FDA to improve on the time it takes the agency to reach its decision on 510(k) and PMA applications to 108 and 300 days, respectively, by the end of FY 2022.

Industry Proposal for New Full-Time Employees  (FTE) at FDA
Head CountProgram Area/Reasoning
30 FTEs"To improve the Pre-Submission process, hold 90% of Pre-Submission meetings within 75 days, and provide written feedback on 90% of Pre-Submissions within 55 days or 5 calendar days prior to the meeting."
20 FTEs "To establish a QM [Quality Management] system."
6 FTEs"To establish an integrated review process model (TPLC) for the Office of Device Evaluation."
21 FTEs"To complete 75% of De Novo submissions within 120 days."
3 FTEs"To complete 90% of Dual 510(k) and CLIA Waiver applications in 180 days, 90% of stand-alone CLIA Waiver applications without a panel meeting in 120 days, and 90% of stand-alone CLIA Waiver applications with a panel meeting in 320 days.
6 FTEs"To provide consistent review of software and issues related to Digital Health."
5 FTEs"To improve the Standards program by establishing a conformance assessment program for certified testing laboratories."

In addition to new staff, industry proposed an additional $6 million for an "independent assessment" of FDA's review process; $4.5 million to build out the "myDevices" portal for device sponsors; $2.5 million to improve FDA's recruiting processes by contracting external recruiters; and $4 million to boost the agency's third-party premarket review program.

However, FDA says that the funding levels being proposed by industry are significantly less than its own estimates in many areas, and do not include resources for several programs, such as a new user fee for evaluating RWE, patient engagement activities and performance-based incentives for FDA managers.

"As it relates to Real World Evidence, industry requested tangible benefits that would be realized to make the premarket process more efficient," FDA says, adding that it would provide industry with the information as soon as possible.

Additionally, the industry proposal skips out on adding more managers and device reviewers that FDA says are necessary to meet its performance goals over the next five years.



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