CDRH: Strategic Priorities: Establishing a National Evaluation System
GOAL #1: Increase access of real-world evidence to support regulatory decisions.
Measurements for 2016-2017: Gain access to 25 million electronic health records with device identification in 2016, and 100 million by end of 2017.
GOAL #2: Increase use of real-world evidence to support regulatory decisions.
Measurements for 2016-2017: Increase premarket and postmarket regulatory decisions using real-world evidence by 40% (compared to baseline FY2015), and increase to 100% by end of 2017.
The National Evaluation System (NES) is a national medical device evaluation system that will provide an infrastructure that will facilitate CRDH to gather evidence to support patient-centered decisions. While CDRH continues to provide a balanced effort of safety and benefits, their establishment of the NES will provide processes that will reduce the time and cost of gathering real-world clinical data.
NES will access data from several sources:
- National and international clinical registries
- Claims data
The NES will focus on accessing “real-world evidence” from everyday interactions of clinicians with their patients, and directly from the patients themselves, by using personal monitoring devices. The real life clinical data captured into EHRs every day, will support safety and effectiveness decisions by the CDRH for regulatory purposes, and clinicians for the best treatment options for their patients. Using available smart phone, computer monitoring technologies, and apps to gather data directly from the clinician and patient-user would push postmarket surveillance into a new paradigm. The system must function to gather data within a quality assured process appropriate to support regulatory decisions. Devices now being uniquely identified (UDI—unique device identifier) will enable the system to track individual patients directly from their EHR and identify potential safety signals in a postmarket environment.
It will be interesting to see if the NES data could be used to support “off label” claims submissions. The NES will present a new paradigm for regulatory decision making by introducing shortened timelines for decisions, seamless transfer of national and international data to regulatory decision makers, and data that more accurately represents real life patient and clinician experiences.
All four parts of these online conversations present a brief view of CDRH’s 2016-2017 Strategic Priorities. More information can be found at the links below. This venue will follow the success of CDRH’s establish benchmarks in 2017.