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New FDA Import Rule takes Effect on October 1, 2012
September 19, 2012
On August 2nd the FDA Published a Final Rule implementing Device Registration and Listing Requirements. The Device Registration and Listing Requirements will take effect on October 1, 2012 when the 2013 Fiscal Year begins.
Foreign establishments that are exporting devices or offering devices for export to the United States must identify and list all known U.S. importers of their devices. This requires them to list their customers all of whom are already required to be registered with the FDA as importers. All establishments that are required to register with the FDA will have to pay the increased annual registration fee of $2,575.
Summary of Specific Changes
Up until Oct. 1, most dental laboratories were classified in FDA registration categories which required no fee to register. Under the new requirements all entities regardless of category that conduct a business activity that requires registration with the FDA have to pay a $2,575 fee annually.
For anyone involved in the import trade process, the new FDA requirements will result in unprecedented transparency. Any foreign dental laboratory sending work to the U.S. will have to supply the U.S. FDA with a list of its customers with detailed contact information (dental laboratories, dentists, group dental practices, address, website, etc.) prior to entry into the US. The information based on the regulation will be public record and available to anyone through the public FDA website.
This new requirement and its impact cannot be understated. These changes will have the greatest impact on entities in the laboratory industry and on the clinical side that have attempted to skirt transparency through technicalities in the law. It appears that the loophole in the system just closed and it will be very difficult to claim you are not going offshore if you are, directly or indirectly.
To read the FDA Final Rule in it's entirety, download it here: FDA Final Rule
Some information in this article was provided by the National Association of Dental Laboratories
Foreign establishments that are exporting devices or offering devices for export to the United States must identify and list all known U.S. importers of their devices. This requires them to list their customers all of whom are already required to be registered with the FDA as importers. All establishments that are required to register with the FDA will have to pay the increased annual registration fee of $2,575.
Summary of Specific Changes
Up until Oct. 1, most dental laboratories were classified in FDA registration categories which required no fee to register. Under the new requirements all entities regardless of category that conduct a business activity that requires registration with the FDA have to pay a $2,575 fee annually.
For anyone involved in the import trade process, the new FDA requirements will result in unprecedented transparency. Any foreign dental laboratory sending work to the U.S. will have to supply the U.S. FDA with a list of its customers with detailed contact information (dental laboratories, dentists, group dental practices, address, website, etc.) prior to entry into the US. The information based on the regulation will be public record and available to anyone through the public FDA website.
This new requirement and its impact cannot be understated. These changes will have the greatest impact on entities in the laboratory industry and on the clinical side that have attempted to skirt transparency through technicalities in the law. It appears that the loophole in the system just closed and it will be very difficult to claim you are not going offshore if you are, directly or indirectly.
To read the FDA Final Rule in it's entirety, download it here: FDA Final Rule
Some information in this article was provided by the National Association of Dental Laboratories
