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CDRH Focusing On New PMA Pathway, Clinical Trials Program In 2014/2015 Priorities

This article was originally published in The Pink Sheet Daily

Executive Summary

CDRH Director Jeffrey Shuren discussed the device center’s two-year strategic priorities with “The Gray Sheet.” The center plans to rebalance pre-market and post-market data collection, when appropriate, and improve the processes for starting up clinical trials in the U.S.

FDA’s device center plans to establish a new PMA pathway for high-risk devices for unmet medical needs and appoint a new director to oversee the pre-market clinical trials program. The plans are part of CDRH’s 2014 and 2015 strategic priorities, released Feb. 5.

This is the first time the device center has released a two-year strategic plan rather than just an annual plan. For 2014/2015, the center is focusing on strengthening the clinical trials enterprise, striking the right balance between pre-market and post-market data collection, and providing excellent customer service.

In an interview, CDRH Director Jeffrey Shuren said the 2014/2015 priorities specifically focus on ways to address barriers to accomplishing their vision for patients in the U.S. to get first-in-the-world access to high-quality, safe and effective medical devices.

“Two of the biggest barriers we identified … were the challenges with the clinical trial enterprise in the U.S. and ensuring we strike the right balance between what’s necessary to demonstrate prior to marketing, before we can let a safe and effective device on the market, and what are the things that we appropriately instead address post-market,” he said.

CDRH’s Entrepreneurs in Residence program, which consisted of a group of outside experts working inside the device center, provided recommendations to the agency last spring on clinical trial reform and balancing pre-market/post-market data collection. (See (Also see "New Metrics For Clinical Trial Oversight Floated By CDRH Entrepreneurs In Residence" - Medtech Insight, 20 May, 2013.).) The goals outlined in the priorities are the initial steps the center is taking to implement these recommendations, Shuren said.

Rebalancing Data Collection

Shuren previously said that the device center is working on a guidance document to establish a framework for when it is appropriate to shift pre-market data collection to the post-market setting. (See (Also see "CDRH’s Shuren Signals More Guidance, Enhanced Pre-Market Payer Role" - Medtech Insight, 22 Aug, 2013.).)

But he now says CDRH is also developing a new pathway for high-risk PMA devices that address unmet medical needs, by shifting some of the evidence burden from pre-market trials to the post-market studies and incorporating features from the center’s prior Innovation Pathway pilots. (See (Also see "CDRH Launches ‘Innovation Pathway 2.0’ With End-Stage Renal Devices" - Medtech Insight, 16 Apr, 2012.).)

“We would look to take features of the Innovation Pathway based upon our experiences with it and incorporate it into a formalized pathway for devices that would be otherwise under a PMA,” he told “The Gray Sheet.”

Also, as part of its priority to rebalance pre- and post-market expectations, Shuren says the center will conduct a retrospective review of all PMA device types to determine whether to shift some pre-market data requirements to the post-market, or to down-classify certain product categories. CDRH hopes to review every PMA device type that has been on the market by December 2015.

This is “a great example of good governance,” Shuren said. The center “will look retrospectively and make sure we have the needle in the right place based upon the state of science today and then ensure we have baked into our processes the ability to look prospectively as technologies come to us moving forward,” he noted.

He added that FDA “should always be in this mode of constantly making sure we revisit, given the state of the science, what the appropriate regulatory expectations should be.”

Clinical Trial Reform

The center is also planning to improve the efficiency, consistency and predictability of the investigational device exemption process to reduce the time and number of cycles needed to reach IDE approval.

This goal includes setting specific targets to reduce the number of IDE review cycles eventually by 50 percent compared to FY 2013 performance by June 2015. Also, the center wants to increase the number of early feasibility/first-in-human IDE studies conducted in the U.S. by June 2015.

To help reach these targets, CDRH plans to release a benefit-risk framework for investigational device exemption clinical trials that will include patient-specific factors, such as individuals’ tolerance of risk and perspective on benefit.

Further, the center plans to establish a pre-market clinical trials program responsible for the oversight and performance of the IDE program within its Office of Device Evaluation. Currently, Owen Faris has been appointed acting clinical trials director, and will report to ODE Director Christy Foreman. The center will conduct a national search to permanently fill the director position.

Also, CDRH released a standard operating procedure for the review of IDEs on Feb. 5. The SOP describes the process for initiating clinical trial director review and collaboration to resolve issues with IDE applications that have led to multiple review cycles.

CDRH typically delegates its IDE approvability decisions to specific review branches, but under this new operating procedure, the clinical trials director would be involved in the review of selected IDE applications to provide an objective review of outstanding issues affecting the IDE.

Staff is expected to apply this SOP to address unresolved issues between FDA and sponsors, despite repeated attempts to resolve them.

Customer Satisfaction, Guaranteed?

CDRH is also prioritizing excellent “customer service” to patients, manufacturers and health care professionals. The center is targeting 90 percent customer satisfaction by December 2015.

CDRH defines excellent customer service as “understanding and addressing, as appropriate, stakeholders’ and colleagues’ needs through active listening, problem solving, seeking out the ideas of others, explaining the rationale for our decision and requests for information, learning from our mistakes, and doing our best.” CDRH issued a “CDRH Standards of Excellence” memo Feb. 5, further elaborating upon these points.

Other actions CDRH plans to take to improve customer service include using a standardized survey tool embedded in emails and on its website. And establishing a program to monitor and address feedback on CDRH processes and services, and improve quality and performance that include corrective action and preventative action processes.

CDRH also released a quality management framework Feb. 5, which includes the center’s quality policy and objectives, management review, competencies and training, process document control, feedback, evaluation, corrective action and preventive action, process improvement, measurement, and data analysis. The framework is broken into five parts: infrastructure, senior management responsibility, resource management, lifestyle management and quality management system evaluation.

Refined Priorities

In previous strategic priority lists, CDRH has listed dozens of actions to address numerous priorities. (See (Also see "Shuren's CDRH Sets Ambitious 2010 Agenda: 510(k), PMA Changes Planned" - Medtech Insight, 25 Jan, 2010.) and (Also see "CDRH In 2012: More Pilots, Guidances And Regs" - Medtech Insight, 30 Jan, 2012.).)

“Every year, that number is going to get less and less and we’re ultimately going to move toward rethinking what our vision should be, and how we move forward to accomplish it,” Shuren said.

“If you look at our progress, that’s exactly what happened – every year that number went down,” he said. “I think in 2011 it was like 67 actions, last year was just 39.” (See (Also see "CDRH Sets 2013 Strategic Priorities" - Medtech Insight, 10 Dec, 2012.).)

Another aspect that is “very, very, very different from our other plans, is that instead of being focused on particular actions and outputs, we’re focused on particular outcomes,” the director explained. “This was always our plan within the center – that we can move away from focusing on the specific stuff to do as opposed to getting us to a certain place and being able to measure it so we can understand whether or not we have succeeded.”

[Editor’s note: This story was contributed by “The Gray Sheet,” your source for in-depth coverage of the medical device and diagnostics industry. For more information call 1-800-332-2181. To register for a free trial, click here/ – no credit card needed.]

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