The FDA’s Center for Devices and Radiological Health this week released a list of its strategic priorities for the upcoming year.
The federal agency’s top goals for the year include establishing a national evaluation system for medical devices, partnering with patients and promoting a culture of quality and organizational excellence, according to the report.
The FDA said a national evaluation system for medical devices that integrated real-world evidence would allow the agency to more efficiently balance the amount of data it collects premarket and postmarket for devices.
“The national medical device evaluation system will build upon and leverage the vast amount of information and knowledge created every day as a part of routine health care or generated at home, such as patients using monitoring devices – what we call ‘real-world evidence.’ Access to the large amounts of electronic clinical data being generated and collected today can be used to identify safety signals and support risk-benefit analyses when data quality is ensured and advanced analytics are applied,” the FDA wrote in the report.
The group set a goal to increase access to real-world evidence for supporting regulatory decision making, aiming to gain access to 25 million electronic patient records by Dec. 31 this year, and 100 million records by Dec. 31 2017.
The agency equally hopes to increase the amount of premarket and postmarket regulatory decisions that use real world evidence by 40% in 2016 and 100% in 2017.
The CDRH said it hopes to promote meaningful patient engagements over the next 2 years as well. The agency aims to establish 1 or more new mechanisms for obtaining patient input on pre and post market issues over the next year, while fostering participation of 10 patient groups.
By 2017, the CDRH hopes to have 20 patient groups participating. In addition, the CDRH hopes to increase the number of CDRH employees interacting with patients 50% by the end of 2016 and 90% by the end of 2017.
By Sept. 2016, the CDRH says it plans to include a public summary of relevant patient data in 50% of its new-device regulatory decisions, and 100% by 2017. Also included in the plans are increasing the amount of patient perspective studies included in regulatory submissions.
Included in the report was a detailed plan for strengthening the FDA’s culture of quality, with more staff receiving quality and process improvement credentials, as well as aiming for ISO 9001 certification.
