On February 12, 2016, the Food and Drug Administration (FDA) released a notice of a public workshop and request for comments. The FDA, in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, is hosting a public workshop titled, ‘‘Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness.’’ This workshop will provide researchers, clinicians, and other medical device industry stakeholders the opportunity to discuss how the FDA can better harness data from sources of “real world” evidence from medical devices, in order to improve the safety and effectiveness of these devices.
This notice states that currently evidence is being collected in a manner that is both high-cost and inefficient. In addition, the current limitations of postmarket surveillance tools creates a disincentive for researchers to study new technologies in the United States. This symposium will examine the potential development of a national evaluation system for medical devices that would help the FDA “strike the right balance between premarket and postmarket data collection, facilitate access to medical devices, and more quickly and robustly identify safety signals that may arise in the postmarket period.”
In 2015, the FDA's Center for Devices and Radiological Health developed the foundation for a national evaluation system for medical devices. Two multi-stakeholder groups issued reports that provide recommendations on furthering the establishment of this system.
The public workshop will take place at the University of Maryland School of Pharmacy on Thursday, March 24, 2016 from 8:30 a.m. to 4:30 p.m.
Registration is available here.
Electronic comments can be submitted in the Federal eRulemaking Portal: http://www.regulations.gov.