Medical device industry representatives told FDA that they are not in agreement with the proposed funding for device user fees. Speaking in late June at a meeting to discuss the reauthorization of MDUFA, they objected to a possible 17% increase from FY 2012 to FY 2013. According to the minutes of that meeting, the industry representatives are against “user fees comprising 40% of the device review budget.”

The representatives do not want CDRH’s budget to rely too heavily on the user fees, and held up the drug review budget, which draws 60% of its funding from user fees, as an example of a direction they don't want CDRH to go in.

The representatives indicated industry is reluctant to commit to a reauthorization of the program before the agency has clarified whether and to what degree it will change device regulations. They proposed reconvening user-fee negotiations within 15 days of the upcoming release of the recommendations by the Institute of Medicine (IOM) on revamping the 510(k) process. The representatives suggested that they could then discuss the report and its potential impact on CDRH’s resources.

“Industry further proposed that FDA would subsequently issue a plan related to each of those recommendations with a workload and resource impact analysis,” the minutes read. The representatives also requested a similar analysis on the 510(k) paradigm, 510(k) modifications, de novo guidance, third-party review program SOPs, and multiple predicate analysis. “FDA provided clarification on the multiple predicate analysis, confirming that FDA is not limiting predicates, but will be clarifying how predicates may be used in accordance with the statute,” the minutes read. “FDA indicated that this clarification is not expected to affect 510(k) workload.”

Additionally, industry asked for more information on CDRH's plans for regulating laboratory-developed tests (LDTs). “Industry is concerned that regulation of LDTs will affect FDA’s ability to meet its performance goals because of increased workload,” the minutes read.

During the meeting, industry also presented four proposals for review program enhancements, including “presubmission meetings, refuse-to-accept procedures for 510(k)s, refuse-to-file procedures for PMAs, and an independent analysis of review process management.”

Another set of minutes from a similar meeting held 10 days earlier disclosed that FDA has rejected an industry proposal for a two-year MDUFA extension, saying the agency still wants a five-year program with decisions on topics that industry identified at a meeting in May.

In their response to the proposal, FDA officials said they did not believe that the proposed two-year extension “addresses key challenges facing the program or that it meets the goal of ensuring timely access to safe and effective products,” according to the minutes. The agency representatives said they “remain interested in engaging in discussions on topics” industry had raised. They “expressed concern that industry’s… proposal had resulted in a delay in making progress towards full reauthorization of the program, which is under a tight statutory timeline.”

According to FDA, the two-year extension “would produce even greater uncertainty about long-term program stability that would exacerbate the turnover problem and reduce staff morale.”

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