19 - Premarket Review of Neurological Devices

Summary

FDA uses a tiered, risk-based classification of medical devices, including neurological devices, in determining the regulatory requirements for the premarket review process. A list of classification regulations for various types of diagnostic, surgical, and therapeutic neurological devices, and their regulatory classification is found in the Code of Federal Regulations (CFR). This chapter provides an overview of the regulatory requirements for each of these classes. FDA has cleared approximately 1800 neurological devices. Among the most prominent neurological devices approved under the premarket approval (PMA) process are the deep brain stimulators (DBS) devices which have been PMA-approved for Parkinson's disease and essential tremor. The Investigational Device Exemptions (IDE) allow the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a PMA. The majority of neurological device issues requiring panel input are brought before the Neurological Devices Advisory Panel.