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US FDA Registration Process for Medical Devices

Medical device registration is a complex process, in part because of the wide variety of items that are categorized as medical devices. They may be simple tools used during medical examinations, such as tongue depressors and thermometers, or high-tech life-saving devices that are implanted in the patient, like pacemakers and coronary stents. This session will take a step by step approach to walk attendees though what is required in the registration process. Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. Among other things, this helps the FDA plan facility inspections and increases their ability to prepare for and respond to public health emergencies. Participants of this session will gain an understanding of the requirements of the registration process.