Post-marketing Requirements Research Articles

An Overview of FDA Medical Device Regulation as it Relates to Deep Brain Stimulation Devices

The United States Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of a variety of medical products and the FDA's Center for Devices and Radiological Health is responsible for premarket and postmarket regulation of medical devices. In this paper, we review--from device classification and clinical studies to the final marketing application--FDA's premarket requirements and postmarket requirements as they relate to deep brain stimulation devices.

Legal and regulatory update

The European Commission has launched a public consultation on its proposed amendments to the Medical Devices Directive (MDD) (Dir 93/42/EEC). The aim of the European Commission's proposals is to improve the coherence, transparency and effectiveness of the legislation governing medical devices in line with the recommendations of the report produced in 2002 by the European Commission's Medical Device Experts Group. This report recommended that the requirements for clinical evaluation of medical devices be clarified, transparency be increased by amending post-market surveillance requirements and that the decision making process be improved by empowering the European Commission to make binding decisions where individual national opinions differ on whether a product falls within the definition of 'medical device'. The report also recommended that the three directives governing medical devices (the MDD, the Active Implantable Medical Devices (AIMD) Directive 90/385/EEC and the In-vitro Medical Devices (IVDD) Directive 98/79/EC) should be made more consistent with each other.

The U. S. Food and Drug Administration's role in contact lens development and safety.

To provide information concerning the U. S. Food and Drug Administration's (FDA) role as a regulatory agency in the development and safe use of contact lenses. The FDA's organizational structure and regulatory classification of medical devices are explained. Specific regulatory authorities are described and examples provided with respect to the FDA's role in the regulation of the new hyper-oxygen permeable continuous wear contact lenses. The application of medical device regulations addresses the rights and safety of subjects in preapproval clinical studies and provides a basis to generate valid scientific evidence to demonstrate the safety and effectiveness of a medical device. Once on the market, there are postmarket requirements with which a manufacturer must comply. For continuous wear 30-day lenses, the FDA is using additional regulatory authorities new to the contact lens area to assure that product safety is maintained and consumer information is improved. These include postapproval studies, more informative labeling, and advertising restrictions. Whereas it is the FDA's mission to promote and protect the health of the public by ensuring the safety and effectiveness of medical devices, the agency works in partnership with other stakeholders to maintain the safe use of medical devices.