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FDA and the Customs and Border Patrol Servic e (CBP) have become increasingly sophisticated and equally demanding in th e submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export p rogram find their shipments delayed\, detained or refused. As of December 2020\, FDA and CBP officially implemented the Automated Commercial Environ ment (ACE) entry filing system. You either meet ACE requirements or face e ntry refusals and monetary penalties of up to $10\,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities o f the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA'\;s thinking\, negotiate with the FDA and off er anecdotal examples of FDA'\;s import program curiosities.
\n\nWhat happens when your product is detained? FDA will begin a legal process that can become an expensive b usiness debacle. You must respond fully within short timeframes. This is n ot the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.
\n\nThe FDA is steadily increasin g the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment\, your product is figuratively dead in the water. You must be accurate with the import codin g information and understand the automated and human review process. If no t\, you can expect detained shipments. CBP is implemented a new "\;Aut omated Commercial Environment"\; computer program that changes import logistics and information reporting for FDA regulated products. Your shipm ent may be stopped before it is even loaded at the foreign port.
\n\nWhen products are refused\, you have different options. Some options may cost more than others. For example\, your product can be seized and destro yed by the government. You may be fined if you do not act in a timely mann er. These are common problems that become prohibitively expensive. You sho uld know how to avoid common problems or at least how to mitigate the cost by using established and effective business planning.
\n\nLearn how to deal with common problems\, such as returns for repair\, importing QC samples\, and investigational products
\n\nOn a positive note\, the FDA is implementing the Voluntary Qualification Importer Program under the FDA Food Safety and Modernization Act. One other perk is that FDA offers export certificates\, for a modest fee\, which may give you a competitive advantage in foreign markets. In some cases\, a FDA export certificate is required by foreign governments. Finally\, the new EU Medical Device Regul ation will change how FDA manages foreign inspections and in your favor. p>\n\n
Casper (Cap) Uldriks \;owns Encore I
nsight LLC\, which provides consulting services on FDA Law. He brings over
32 years of experience from the FDA. He specialized in the FDA'\;s med
ical device program as a field investigator\, served as a senior manager i
n the Office of Compliance and as an Associate Center Director for the Cen
ter for Devices and Radiological Health. He developed enforcement actions
and participated in the implementation of new statutory requirements. He i
s recognized as an exceptional and energetic speaker. His comments are can
did\, straightforward and of practical value. He understands how FDA think
s\, operates and where it is headed.
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\nJOA180521CEV
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SUMMARY:Tougher Import Rules for FDA Imports in 2020
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SUMMARY:Tougher Import Rules for FDA Imports in 2020
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