Regulatory Framework for Implantable Neurostimulation Devices: Comparison of Systems in the US and European Union.

ABSTRACT

BACKGROUND: Implantable neurostimulation devices must be authorized before they are placed on the market. For this purpose, requirements, and processes for assessing their fulfillment, have been defined in different jurisdictions. OBJECTIVE: In this study, we aimed to address differences between the US and European Union (EU) regulatory systems and their relationship to innovation. MATERIALS AND METHODS: A literature review and analysis were conducted using legal texts and guidance documents. RESULTS: The US system has one central body, the Food and Drug Administration, whereas the EU system has several bodies with different responsibilities. The devices themselves are divided into risk classes, which are based on the vulnerability of the human body. This risk class determines the intensity of the review by the market authorization body. In addition to the requirements for development, manufacture, and distribution, the device itself must meet technical and clinical requirements. Compliance with technical requirements is indicated by nonclinical laboratory studies. Proof of efficacy is provided by means of clinical investigations. Procedures are defined for reviewing these elements. Once the market authorization process has been completed, the devices can be placed on the market. In the postmarketing phase, the devices must continue to be monitored, and measures must be initiated, if necessary. CONCLUSIONS: Both US and EU systems are intended to ensure that only safe and effective devices find their way to and remain on the market. The basic approaches of the two systems are comparable. In detail, however, there are differences in ways these goals are achieved.