FDA's first crack at an industry user fee reauthorization proposal did not change review goals for 510(k)s, but did suggest some new processes to shorten overall review times for 510(k)s and PMAs alike.

Industry has not taken total-time review goals off the table, Medtronic's Pat Shrader says.

During April 13 negotiations with industry, the agency proposed to continue attempting to review 90% of 510(k)s within 90 FDA days and 98% of 510(k)s within 150 FDA days.

Instead of changing the 510(k) review goals, FDA proposed new "program efficiencies." For one, the agency is considering implementing a new "refuse-to-accept" policy that would screen out incomplete pre-market submissions from the start.

CDRH leadership has been pressing industry to take more responsibility for the quality of pre-market submissions and the subsequent delays that poor submissions can cause. (See " Also see "Shuren On The Hill: Industry Should Take More Blame For Review Delays" - Medtech Insight, 21 February, 2011. " – "The Gray Sheet" Feb. 21, 2011.)

"FDA receives a large number of incomplete submissions," the agency reiterated in recently released minutes from the closed-door meeting April 13 in Silver Spring, Md.

Industry reps at the meeting said they disagreed with FDA's definition of submission quality. The agency is considering clarifying in guidance what constitutes a complete submission.

Under the proposal, FDA would revise its "refuse-to-accept" checklists for investigational device exemption and 510(k) submissions, and add a refuse-to-accept checklist to the existing "refuse-to-file" criteria for PMAs.

IDEs that are not accepted would automatically be converted to pre-IDE submissions, FDA suggested.

Mandatory Interactive Review Tracking

In an attempt to resolve the shortcomings in its "interactive review" program, FDA is also considering making it mandatory to report the time that reviewers spend interacting informally with sponsors. (See " Also see "Interactive Review May Be Revamped In 2012 User Fee Agreement" - Medtech Insight, 2 May, 2011. " – "The Gray Sheet" May 2, 2011.)

For both 510(k)s and PMAs, FDA would create an "interaction goal" for when reviewers would either communicate issues to sponsors or provide a status update.

FDA would only mandate interactive review tracking, not use of interactive review.

Fostering Innovation

FDA also proposed ways to foster innovation as part of its user fee proposal. The agency said it could:

Develop and share a clinical investigator list
Expand and make permanent a pilot training program for clinical investigators
Develop a certification program for clinical research sites
Create an infrastructure for nesting mandated post-approval studies in existing clinical registries

"There are instances where [interactive review] is not needed, or the problems with the submission are better communicated through an additional information or major deficiency letter," the agency explained.

Finally, FDA is considering whether to email or fax letters to sponsors to allow them to respond more quickly, the meeting minutes indicated.

For these suggestions to be effective, FDA will need additional program resources, the agency maintains.

FDA says the key objectives of its user fee proposal are predictability, consistency, efficiency and transparency.

To achieve these, the agency hopes to enhance capacity, manage workload better, improve interaction between FDA and sponsors, and foster innovation.

510(k) Goals Aren't Aggressive – Industry

Industry reps at the negotiations argued that FDA's proposals do not adequately take into account the importance of the 510(k) program.

Early on, industry had been hoping that FDA would focus on reducing total time to market, which has steadily increased over the years. The average total time to market for a 510(k) product is now more than 270 days, device makers say.

FDA is hesitant to hold itself to a performance goal that is not entirely within its control. But according to Pat Shrader, VP of corporate regulatory affairs at device maker Medtronic, total-time review goals are not completely abandoned.

"Industry has not taken it off the table," she told "The Gray Sheet."

FDA has been meeting its current performance goals for 510(k)s, but acknowledges that the average number of 510(k) review cycles and total review times have been increasing.

Shrader argued that the current review goals for 510(k)s are not particularly aggressive in the first place.

"The goals that were set for 510(k)s in MDUFA II were not aggressive goals. They were reflective of the FDA performance at the time," Shrader said at the Association of Medical Diagnostics Manufacturers annual meeting April 29. "That was done deliberately to enable FDA to focus on PMAs, to focus on doing guidance documents."

At a May 5 CDRH "Town Hall" meeting in Orlando, Fla., Director Jeffrey Shuren said he could not discuss the user fee proposal in detail because negotiations are ongoing, but he noted that "our goal is to make the pre-market programs and our pre-market reviews work as optimally as we can."

"That includes assuring that we have the right processes in place, that we have an adequate number of staff to accomplish reviews in a practical amount of time, and that we have the cooperation of industry as well – that we are receiving quality submissions," Shuren said.

Rather than focusing solely on how many FDA days it takes to review a product, "we're considering the program as a whole, what it will actually take during the review process for making a decision and how we can make that overall process work as efficiently and effectively as possible."

FDA said it could measure its success in fewer review cycles per 510(k), shorter total time to a final FDA decision, and smaller differences in review time between the highest- and lowest-performing branches.

User fee talks continued at a May 4 meeting in Silver Spring. The FDA user fee agreement must be reauthorized by September 2012.

By Jessica Bylander

FDA Says User Fee Proposal Could Shorten Total Pre-market Review Times

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