Title :
FDA Regulation of Invasive Neural Recording Electrodes: A Daunting Task for Medical Innovators
Author :
Welle, Cristin G. ; Krauthamer, Victor
Author_Institution :
Div. of Phys., FDA, Silver Spring, MD, USA
fDate :
3/1/2012 12:00:00 AM
Abstract :
In this paper, the basics of FDA regulatory premarket process were introduced that relates to chronically implanted recording devices in the central or peripheral nervous system.
Keywords :
ISO standards; biomedical electrodes; market research; neurophysiology; prosthetics; regulation; FDA regulatory premarket process; central nervous system; chronically implanted recording devices; invasive neural recording electrodes; market research; medical innovators; peripheral nervous system; Clinical trials; Commercialization; Drugs; ISO standards; Reliability; Testing; US Food and Drug Administration; Clinical Trials as Topic; Device Approval; Diagnostic Techniques, Neurological; Electrodes, Implanted; Equipment Safety; Humans; United States; United States Food and Drug Administration;
Journal_Title :
Pulse, IEEE
DOI :
10.1109/MPUL.2011.2181022
