End of FDA Exemption for Some de Minimis Products Likely Won't Affect Clearance Times, Feldman Says
The FDA’s decision to begin requiring partner government agency filings for some previously exempt products could have an impact on some companies, though generally its effects on the trade will be limited by widespread use of Type 86 filing and the recent end of de minimis for China, Lenny Feldman of Sandler Travis said in an interview.
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As relayed in a CSMS message July 9, the FDA said that “effective immediately” it will require PGA filings for five categories of products regulated by the agency that had been exempt from its PGA filing requirements since 1994. The exemption had applied to cosmetics, dinnerware, radiation-emitting non-medical devices, biological samples for laboratory testing and most foods.
With PGA data now required, non-Type 86 de minimis filers using regular Section 321 clearance are no longer able to use that option for the previously exempt products. Cosmetics companies that ship direct to consumers using Section 321, for example, would be particularly affected by the change, having to file the additional data required by the FDA for other products regulated by the agency, Feldman said.
Feldman is optimistic that the additional PGA filings caused by the change won’t cause issues with clearance times. He said the FDA is set to soon roll out a “national review” functionality that relies on AI and machine learning and other technologies, so “they should be able to handle the additional volume that’s going to come of this.”
In the CSMS message, the FDA said that the “technological capabilities of both the trade and the FDA have advanced significantly” since the PGA filing exemption was created in 1994. “This allows FDA to review all electronically transmitted FDA-regulated products offered for import, regardless of shipment quantity and value, to facilitate legitimate trade and prevent the importation of violative products,” it said.