Device Evaluation System Tops FDA’s Strategic Priorities

The FDA plans to establish a system that would allow for the use of “real-world evidence” to help the agency more quickly identify safety signals and address concerns, according to its list of strategic priorities for 2016-2017.

The infrastructure, dubbed the National Medical Device Evaluation System, would use electronic clinical data, such as electronic health records, registries and medical billing claims in which device identifiers have been incorporated.

The agency aims to gain access to 25 million electronic patient records with device identification by Dec. 31, and 100 million records by the end of next year. The FDA also aims to increase the use of real-world evidence to support regulatory decisions by 40 percent by the end of this year and by 100 percent by Dec. 31, 2017.

The goals come as a new Senate report calls on Congress to require unique device identifiers to be included in insurance claims and fully fund a National Medical Device Evaluation System to ensure that the FDA is able to effectively monitor the safety of devices on the market rather than relying on adverse event reporting (see related story).

The FDA’s list of strategic priorities also aims to boost patient interaction to advance the development and evaluation of innovative devices and monitor the performance of marketed devices. By Dec. 31, 2017, 90 percent of CDRH employees will interact with patients as part of their job duties, according to the goals.

Another goal aims to increase the use of patient input in the agency’s decision making. By Sept. 30, 2017, 100 percent of PMA, de novo and humanitarian devices exemption decisions will include a public summary of relevant patient perspective data considered. By that same date, the agency will increase the number of patient perspective studies used in support of premarket and postmarket regulatory decisions, and increase the number of expedited access pathway data development plans or regulatory submissions that consider patient perspectives.

In addition, the agency plans to strengthen its culture of quality, setting a goal to increase by 25 percent the number of CDRH staff with quality and process improvement credentials by Sept. 30, 2017.

The agency also highlighted its accomplishments in the past two years towards its 2014-2015 Strategic Priorities, including:

• Establishing a clinical trials program, developing clinical trials education for staff and industry, developing new policies and processes and establishing investigational device exemption performance metrics;
• Conducting a retrospective review of all 210 high-risk device product codes, which required more than 275 postmarket analyses, resulting in a reduction in premarket data requirements and/or a recommendation to downclassify a technology for about 30 percent of the product codes;
• Establishing a regulatory pathway for breakthrough devices that, when appropriate, allows for shifting appropriate premarket data needs to the postmarket setting; and
• Completing 14 premarket process improvement projects, resulting in the implementation of all 11 recommendations stemming from the MDUFA III assessment of the premarket review process.

Read the CDRH 2016-2017 Strategic Priorities here: www.fdanews.com/01-16-FDA-Priorities.pdf and the CDRH 2014-2015 Strategic Priorities Accomplishments here: www.fdanews.com/01-16-FDA-Accomplishments.pdf. — Jonathon Shacat