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U.S. FDA Medical Device Regulations

Medical Devices

The U.S. Food and Drug Administration (FDA) regulates medical device products intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease intended to affect the structure or any function of the body of humans or other animals. Registrar Corp provides Registration, U.S. Agent, and Regulatory Compliance Assistance for U.S. and Non-U.S. Companies in the Medical Device Industry.

Medical Device Establishment Registration and Listings

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 FDA annually. Firms involved in manufacturing, packaging, labeling or reprocessing of devices must pay an annual fee. Many establishments that are required to register with FDA also are required to list their devices.

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Electronic Medical Device Reporting (eMDR)

FDA now requires medical device manufacturers and importers to submit adverse event reports in electronic format. Device manufacturers and importers are required to submit adverse event reports to FDA when evidence suggests a device may have contributed to a patient death or serious injury, or when a device malfunctions and reoccurrence of the malfunction would likely contribute to death or serious injury.

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Unique Device Identifier (UDI) and Global Unique Device Identifier Database (GUDID)

Most medical devices distributed in the U.S. are required to include a numeric or alphanumeric code as a unique device identifier (UDI). FDA also requires submission of device and UDI information to the Global Unique Device Identifier Database (GUDID).

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Medical Device Labeling and Product Reviews

Labeling errors are one of the leading causes of FDA detentions. Registrar Corp helps companies modify medical device labeling to comply with FDA regulations. Registrar Corp provides 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 documents from FDA.

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Data Universal Numbering System (D-U-N-S®)

The Data Universal Numbering System (D-U-N-S®) is a business identification system operated by the private company Dun & Bradstreet®. Medical device establishments with devices subject to FDA UDI requirements must obtain a D-U-N-S® number.

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Medical Device Master Files (MAF)

A Medical Device Master File 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.

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Medical Device Color Additives and Medical Device Color Batch Certification

A medical device color additive is any dye, pigment, or other substance that can impart color to a medical device. Medical device color additives are regulated by FDA.

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Certificate of Registration issued by Registrar Corp

Device establishments registered with FDA are often asked by their customers and suppliers to verify their FDA registration. A Certificate of Registration issued by Registrar Corp serves as a third party verification of your FDA registration.

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Detention Without Physical Examination ("DWPE") Assistance

Companies shipping products to the United States may find their shipments subject to “Detention Without Physical Examination” by FDA. Products subject to detention without physical examination are held at the port of entry while FDA performs additional scrutiny, testing, and analysis. Delays from detention without physical examination may be lengthy for businesses anxious to deliver products on schedule.

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Export Certificates to Foreign Governments

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an “Export Certificate” for products regulated by FDA. An Export Certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.

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