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Category Archives: FDA
Medical Device Excise Tax
A part of Obama’s Affordable Care Act included a 2.3% excise tax on medical devices. I had one importer inquire about the excise tax today and the method for paying it. Unlike the Federal excise tax on alcohol, this tax … Continue reading
Posted in blog, FDA, Medical Devices
Tagged 2.3%, affordable care act, FDA, medical device excise tax, obama
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Changes to Food Facility Registration under FSMA
Food manufacturers, exporters, and importers should all be familiar with the FDA Food Facility Registration requirement. What they may not be aware of are changes to the requirement as a result of the Food Safety Modernization Act that was signed … Continue reading
FDA- Multiple Locations and Medical Establishment Registration
Now that FDA has indicated that they will be charging importers for Establishment Registration, some importers have asked me to clarify whether they need to register each and every facility that receives goods. For example, the importer may have a … Continue reading
Important Update – Changes to Medical Device Establishment Registration Requirements!
This is an important update for all importers who have registered Medical Device Establishments with the FDA. Owners or operators of businesses that are involved in the production and distribution of medical devices intended for use in the United States … Continue reading