Regulatory controls for the United States market entry of medical device : Case flow cytometry

Abstract

In this thesis the regulatory controls for the United States market entry of medical devices are being investigated, using flow cytometer as an example of a medical device. The aim of this thesis is to find out what are the applied regulatory controls of flow cytometers required to be applied and undertaken in order to legally market the device in the United States. Flow cytometry is an effective tool for analyzing different characteristics of cell populations. The results can be used for diagnostic and therapeutic purposes and therefore the devices must be proven to be safe and effective. The legislation and regulation in the United States will be covered thoroughly, including the role of the Food and Drug Administration, United States Code and Code of Federal Legislation as well as the classification of medical devices. It will be found that a flow cytometer is a class II device that requires 510(k) submission to be marketed in the United States. Class II devices are subject to general and special regulatory controls. General controls are the minimum requirements for the assurance of safety and effectiveness. One of the subparts under general control includes the Current Good Manufacturing Practices (CGMPs), which have a big effect on the quality system the medical device manufacturer should implement and follow. When general controls alone are not enough, device-specific special controls are required. Investigating the regulatory controls of flow cytometers is important so the manufacturers can implement the regulations for the assurance of safety and effectiveness and provide innovations to the market, therefore being able to contribute to the growth and success of the whole industry. This would then benefit patients, clinicians, and researchers around the world.