CDRH Looks to Streamline MDUFA Process

FDA’s Center for Devices and Radiological Health is considering streamlining the medical device user fee process to lower costs and create more dialogue with industry.

As part of that process, the FDA is creating a new evidence-based national system that would offer interoperability and connectivity to enable more data sharing among devicemakers and the agency, said CDRH Director Jeffrey Shuren.

Called “EvGen,” the system would help companies apply proven analytical methods to produce more reliable data, he said during the Medical Device Manufacturers Association meeting in Washington on May 5.

He explained that for clinical trials, there are shortfalls in generating scientific evidence that support medical product evaluation and evidence-based methods. EvGen would serve as an umbrella for all activities to inform stakeholders on how to make decisions.

EvGen aims to break down barriers to data sharing by:

• Establishing a common approach to how data is presented, reported and analyzed with strict data security methods;
• Developing rules of engagement through a process that builds consensus across stakeholders; and
• Ensuring support across a dynamic system that includes competition, but is accessible to all stakeholders.

In tandem with EvGen, the agency is also establishing a National Device Evaluation System that would build on real-world data from clinical trials, electronic health records and medical device registries.