Public Workshop – Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop, November 19

The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, “Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop.” The focus of the first day of the workshop will be cognitive assessment medical devices, which are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. The focus…

Public Workshop – Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop, November 19

The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, “Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop.” The focus of the first day of the workshop will be cognitive assessment medical devices, which are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. The focus…

Patient and Consumer Stakeholder Meeting

Purpose: To discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA). During these meetings, representatives from patient and consumer advocacy groups can hear updates on the FDA-Industry negotiations and provide their suggestions for improving the program. The statutory authority for MDUFA expires September 30, 2017. At that time, new legislation will be required…

Patient and Consumer Stakeholder Meeting

Purpose: To discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA). During these meetings, representatives from patient and consumer advocacy groups can hear updates on the FDA-Industry negotiations and provide their suggestions for improving the program. The statutory authority for MDUFA expires September 30, 2017. At that time, new legislation will be required…

Stakeholder Meeting

Purpose: To discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA). During these meetings, participants will hear updates on the FDA-Industry negotiations and will provide their suggestions for improving the program. The statutory authority for MDUFA expires September 30, 2017. At that time, new legislation will be required for FDA to continue collecting…

FDA's Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology

NOTE: The data in this report is current as of March 31, 2015. This data is updated quarterly and can be found on the CDRH MDUFA website at http://www.fda.gov/forindustry/userfees/medicaldeviceuserfee/ucm452535.htm. Table of Contents Printer-Friendly PDF (2.7 MB) 1 the underlying premise that industry’s perception of FDA oversight can affect decisions about introducing new technology in the…