FDA update 9th July 2011

Minutes Meeting on MDUFA III Reauthorization:

Purpose of meeting: To discuss FDA's response to Industry's June 1 alternative proposal, and approaches for mitigating program uncertainty.

• FDA offered its response to Industry's June 1, 2011 proposal for a two-year extension of MDUFA. FDA explained that the agency does not believe the proposal addresses key challenges facing the program or that it meets the goal of ensuring timely access to safe and effective products.
• Based on the conclusion of the May 4, 2011 meeting, FDA expected a proposal from Industry for a 5-year program covering topics that Industry had identified on May 4th and agreed to elaborate on at the next meeting: guidance development, third-party review, Pre-IDE/IDE process, improved tracking of premarket review, more detailed reporting at quarterly meetings, and CLIA waiver application goals.
• FDA remains interested in engaging in discussions on those topics. FDA expressed concern that Industry's June 1 proposal has resulted in a delay in making progress towards full reauthorization of the program, which is under a tight statutory timeline.
• Industry stated that MDUFA II included funding for retention incentive pay, and provided FDA with a spreadsheet from the MDUFA II negotiations. Industry stated its view that the contrast agent guidance document had not met the shared goals of Industry and FDA under the MDUFA II qualitative goals.
• FDA pointed out that the goal was for FDA to issue the guidance, which it did; and even if FDA issued a new guidance, the agency could not be sure whether Industry would be happy with it or not.
• Similarly, Industry appeared to suggest that FDA has not met commitments related to down classification of IVDs. FDA pointed out that its obligation was to review Industry's list of proposed down classifications, which the agency has done; the commitment did not revolve around a particular result.
• Industry has expressed a strong concern with increasing total elapsed time to 510(k) decisions; FDA agrees that this should be addressed in MDUFA III.
• FDA analyzed data to understand the underlying phenomenon and developed their April 13, 2011 proposal with the intent of addressing its root causes.
• The problem of increasing total elapsed time appears to be driven by a combination of increasing numbers of cycles and increasing time Industry takes for each cycle. FDA believes the solution is not simple and involves investing resources in the program to support the changes outlined in FDA's proposal package. FDA does not believe Industry's June 1, 2011 proposal will result in a reversal of this trend.

Conclusion: Based on the day's discussions, Industry offered to bring to the next meeting a counter-proposal for a process for addressing the uncertainties identified by Industry and detailed proposals for enhancements to the MDUFA program.

For more information on meeting minutes you  can go to the following link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm262192.htm or contact mdi at info@mdiconsultants.com REF: MDUFA meeting.