The FDA division of the Center for Device and Radiological Health (CDRH) began the Patient & Care-partner Connection Program (PCC). NASCIC was one of fourteen organizations invited to be involved with the pilot program. During this test phase, we are working with the PCC program to help the program evolve and help the FDA/CDRH gain a better understanding of the needs of the spinal cord injury community.
Earlier this year, NASCIC worked with the FDA PCC program and sent a survey to the SCI community. The purpose of the survey was to gain insight into the SCI community’s perspective on medical devices and the general processes of interacting with the FDA. While the final results are still being analyzed, we wanted to share some preliminary data with you.
One of the questions in the survey addressed the issue of Medical Device Reporting. This is one of the surveillance tools that the FDA uses to monitor medical device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of products that are currently in use by patients and caregivers. The FDA encourages health care professionals, consumers and caregivers to submit reports about serious adverse events that may be associated with a medical device. This includes use errors, product quality issues and therapeutic failures.
The recent survey asked the community if they were aware of this ability to report medical device problems to the FDA. Over half (54%) of the survey respondents were not aware of this program to report adverse interactions with medical devices. To learn more about the MDR program, here is the link.
Medical Device Reporting (MDR): How to Report Medical Device Problems
Manufacturers, Importers, and Device User Facilities: This page is designed to provide you with information on…
In this same survey, the FDA asked the SCI community about FDA-related topics about medical devices. The top responses were information about new medical devices, participation in clinical trials and access to medical devices.
To search for active clinical trials, please visit and register on SCITrials.org
SciTrials.org - Spinal Cord Injury Trials
SciTrials lets you find, learn about and apply for clinical trials for Spinal Cord Injuries.
More information from this FDA/CDRH Patient and Care-partner Connection Program will be coming soon.