U.S. FDA Medical Device Establishment Registration and Listing
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.
U.S. FDA 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.
U.S. FDA Electronic Medical Device Reporting (eMDR)
FDA 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.
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).
U.S. FDA 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.ALN’s team of medical device regulatory experts provides guidance as to required elements, formats, and particularities of Medical Device Master File submissions.
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.
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.