Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States are required to register with the FDA annually. Firms involved in manufacturing, packaging, labeling or reprocessing of devices must pay an annual fee. Most establishments that are required to register with the FDA also are required to list their devices.

Certain medical devices require clearance by the U.S. FDA before they may be sold in the United States. To obtain this clearance, companies must file an application with scientific and technical information sufficient to demonstrate that the device is substantially equivalent to a device already legally marketed in the U.S.

Registrar Corp can help modify your medical device labels to comply with FDA requirements. Registrar Corp's service includes revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts and other guidance from FDA.

A MAF is a submission to FDA that may be used in support of premarket submissions to provide confidential detailed information about establishments, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more medical devices. Registrar Corp's team of medical device regulatory experts provides guidance as to required elements, formats and particularities of medical device master file submissions.

Companies registered with FDA often are asked by their customers and suppliers to verify their registrations. A Certificate of Registration issued by Registrar Corp serves to verify your registration.