The device center plans to propose a new national comprehensive post-market surveillance strategy this spring.

CDRH Director Jeffery Shuren says the goal will be to establish an infrastructure that both FDA and industry can leverage, not only to make post-approval data collection more effective and less burdensome but also to contribute to a faster, less-costly pre-market process.

The national strategy is one of CDRH’s 2012 priorities. The center will issue its proposed post-market strategy by April 30, which will be followed by a public meeting with stakeholders this spring. CDRH plans to finalize the framework by Oct. 31, Shuren says. (See Also see "CDRH In 2012: More Pilots, Guidances And Regs" - Medtech Insight, 30 January, 2012..)

“At this point, there has not been a national dialogue about what a post-market surveillance system for medical devices should look like in the U.S. and we do believe it is a valuable dialogue to have,” Shuren said in an interview.

Shuren described FDA’s current post-market system as “pretty good,” but admitted “it’s not really the system the nation deserves.”

“We have adverse event reporting that gives us some information, but we don’t have a truly robust data collection that we really need,” Shuren said at a Feb. 15 House subcommittee hearing.

The national strategy follows a recommendation from the Institute of Medicine in its analysis of the 510(k) program last July advising the agency to “develop and implement a comprehensive strategy to collect, analyze and act on medical device post-market performance information.” (See Also see "Institute Of Medicine On 510(k) Review Program: Dump It" - Medtech Insight, 1 August, 2011..)

IOM Post-Market Recommendations

In its July 2011 510(k) report, the Institute of Medicine advised FDA to beef up its post-market system by better utilizing current tools and authorities. Other recommendations called for FDA to:

Explore how to understand potential device risks better with existing post-market tools, such as device tracking and Section 522 surveillance studies.
Expand collaborative relationships with existing non-FDA medical device data sources and encourage standardization of processes and systems to increase efficiency and the ability of all parties to use the data.
Institutionalize integration of pre-market and post-market data systems.
Identify methods for learning from independent clinical research reported in pre-reviewed literature on poor or adverse health outcomes related to devices that may warrant FDA action.
Revise its strategy to communicate more effectively with consumers, providers and the public about problems with the performance of medical devices.

Source: Institute of Medicine report – “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years”

While Shuren declined to provide many details on exactly what the post-market strategy would actually entail, he said it would likely involve the use of more registries for devices, as well as “a variety of different components to gather information in the post-market setting.”

Shuren also said that companies could use the robust data collected in this new post-market strategy to aid in the pre-market setting.

“Post-market surveillance isn’t just about more rapidly and better understanding the benefit-risk profile of devices FDA has approved or cleared but can also be used as a tool to gather information to support pre-market approval or clearance of either new devices, or changes or expanded use of devices already on the market,” he said.

FDA intends to work with all stakeholders in developing the strategy, including industry, health care professional societies, third party payers, health care systems, patients and consumers.

“We’ll lay out our perspective on a vision, but we truly see this as a collaborative opportunity and a collaborative undertaking,” he said.

Potential Benefits: Pre- And Post-Market

Identifying safety problems with marketed products as quickly as possible is a core goal of any post-market surveillance strategy.

“If we identify a new risk or problem, it’s far better for patients and for the company if that is identified quickly, and with fewer patients being exposed,” Shuren said. The agency and the company are then able to act more quickly to issue risk communications, and take further actions if necessary, such as initiating recalls or changing device labeling, he explained.

But the device director is also selling the forthcoming strategy as a major time- and resource-saver for companies.

He explained that information generated in a post-market setting could give FDA a better understanding more quickly about the benefit-risk profile of a certain device type. If FDA finds the profile to be very strong, Shuren said the agency could potentially ask for less data for future devices in that product type.

Secondly, he said firms could use data collected as part of broader post-market surveillance system in a pre-market study for a new device. For instance, if there is a registry set up for a certain type of device a company could employ data collected in the registry as one arm of a clinical trial to assess their new device against, rather than setting up a separate control group.

“You can use data collected in post-market surveillance system about another device, and do the non-inferiority study. That allows you to do that study at lower costs, and more quickly,” Shuren said.

A more robust post-market surveillance system in the U.S. could also lower costs for companies that are required to conduct post-approval studies as they could use data from existing registries.

“If you have a good post-market surveillance system, you might be able to leverage that infrastructure to perform the [post-market] study,” Shuren said.

As an example, he pointed to the newly established transcatheter aortic valve registry by the American College of Cardiology and the Society of Thoracic Surgeons, which Edwards LifeSciences will rely on to satisfy some of its post-market study requirements tied to the recent approval of its Sapien valve. (See Also see "Edwards Wins Approval For Sapien Just In Time For TCT" - Medtech Insight, 7 November, 2011..)

“So in essence the cost for doing post-market studies could dramatically drop for companies,” Shuren said. “This is not about our changing what a company would be required to do in a post-market setting – it’s actually allowing them to do [a post-market study] more quickly at lower costs because the infrastructure is already available.”

Shuren Touts Pre-Market Benefits Of Planned National Post-Market Strategy

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