Here are nine changes to device registration and listing requirements, effective Oct. 1.
• All proprietary names under which a device is marketed must be reported, at a minimum, when a device is first listed and during the annual update of registration and listing information.
• Combination products — products comprising a device and a biological product or a drug — must be identified as a combination product and the type of combination product must be selected from the list displayed in the FDA Unified Registration and Listing System.
• All contract manufacturers and sterilizers of finished devices must register and list regardless of whether they put the device into commercial distribution or return the device to the manufacturer or specification developer.
• Initial importers must identify the manufacturers of the devices they are importing.
• Foreign establishments that are exporting devices or offering devices for export to the United States must identify all known U.S. importers of their devices.
• A device must be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer or repacker/relabeler before a foreign exporter, contract manufacturer or contract sterilizer can list it.
• Establishments that only handle complaints and previously registered as manufacturers or specification developers should change their establishment type to "Complaint File Establishment."
• Establishments located in foreign trade zones must now register and list, as well as identify themselves as being located in a foreign trade zone.
• All establishments that are required to register must now pay the annual registration user fee.
• All proprietary names under which a device is marketed must be reported, at a minimum, when a device is first listed and during the annual update of registration and listing information.
• Combination products — products comprising a device and a biological product or a drug — must be identified as a combination product and the type of combination product must be selected from the list displayed in the FDA Unified Registration and Listing System.
• All contract manufacturers and sterilizers of finished devices must register and list regardless of whether they put the device into commercial distribution or return the device to the manufacturer or specification developer.
• Initial importers must identify the manufacturers of the devices they are importing.
• Foreign establishments that are exporting devices or offering devices for export to the United States must identify all known U.S. importers of their devices.
• A device must be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer or repacker/relabeler before a foreign exporter, contract manufacturer or contract sterilizer can list it.
• Establishments that only handle complaints and previously registered as manufacturers or specification developers should change their establishment type to "Complaint File Establishment."
• Establishments located in foreign trade zones must now register and list, as well as identify themselves as being located in a foreign trade zone.
• All establishments that are required to register must now pay the annual registration user fee.
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