Providing accurate and complete information is critical when submitting an import entry to the US Food & Drug Administration (FDA) for timely review, the US agency has urged.
Speaking at the opening keynote of the 17th Annual Clinical Trial Supply West Coast 2024 conference in San Francisco, the FDA highlighted how manufacturers are making avoidable errors when submitting device information for review.
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Representatives from the FDA’s Division of West Coast Import unit shared the most common entry errors that result in delayed shipments. According to the agency, importers submitting incorrect Affirmation of Compliance (AofC) information is the top mistake. The AofC confirms that the imported product meets all the legal requirements enabling it to be sold in the US. Submitting the wrong AofC information can delay initial screening and review of an entry.
“Make sure you are vetting your filer,” said Sylvia Thomas, Supervisory Consumer Safety Officer at the FDA Division of West Coast Imports. “Make sure your filer understands the whole process, because a good filer will not only expedite the process for you, but also handle the logistics.”
Thomas explained how an efficient filer should be familiar with the documentation requirements and be able to identify what information, if any, is missing and resolve it on behalf of the importer.
Other common errors being made by importers are submitting incorrect manufacturer information, product codes and shipper information, the FDA said.
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By GlobalData“The truth is we really want to release your product as fast as possible so we can spend time on more suspicious cases,” said Thomas. “We understand that the import process can be challenging but avoiding these preventable errors will expedite the process for you considerably.”
The 17th Annual Clinical Trial Supply West Coast 2024 conference is taking place in San Francisco from 17-18 September.
