Additional ACE Filing Required for Stand-Alone LEDs, Not Articles, FDA Official Says
Entry filers must transmit data required by the Food and Drug Administration for stand-alone light-emitting diodes, but don’t have to for finished products that incorporate LEDs as indicator lights, FDA Director of Enforcement and Import Operations Doug Stearn said in a letter to the National Customs Brokers & Forwarders Association of America dated May 25 (here). The NCBFAA had requested clarification of LED reporting requirements in April. Stearn said FDA recently discovered that some LED products, subject to FDA reporting requirements for radiation-emitting electronic products, were not being transmitted to FDA for review.
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FDA has since updated the “FD” flag for the offending subheading, 8541.40.2000, so that it is now “FD2,” the flag for FDA-regulated products other than food. “FDA expects the transmission of entry data for products falling under HTS code 8541.40.2000: LED products used for general or local area illumination, such as lamps and lightbulbs, are of special interest to FDA and must be submitted to FDA for review,” Stearn said. But LEDs are not subject to performance standards, so Form FDA 2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, “should not be submitted for LED products and no affirmation of compliance is required for submission in ACE.”
On the other hand, while FDA is still considering which non-medical LED-containing products do not have to be declared, for now, FDA does not expect transmission of entry data for finished products that incorporate LEDs in indicator lights, like those used in toys, tablets, cellphones, shoes, household appliances, entertainment systems, remote controls, or other products not otherwise regulated by FDA, Stearn said. “These types of products do not fall under HTS code 8541.40.2000 and are not indicated for entry submission to FDA,” he said.
“When entry information related to LEDs is submitted to FDA, the submission requirements will depend on whether the product is a non-medical product or an LED integrated into a medical device,” Stearn said. For medical devices, if the LED is being imported for use as a component to be incorporated into a medical device after importation, then the manufacturer of the LED should be transmitted to FDA as the manufacturer of the FDA regulated component, he said. “If the LED has been incorporated into the medical device prior to importation, transmit the manufacturer of the finished medical device.”
FDA to Emphasize ‘Education Before and While We Regulate’ for FSVP
In the same letter, Stearn also echoed recent remarks from FDA officials on the agency’s enforcement approach for new Foreign Supplier Verification Program requirements that took effect May 30. “Because FSVP is a new rule and FDA has not previously regulated FSVP importers in this manner, the FDA has adopted an initial approach that emphasizes education before and while we regulate,” he said. “The goal of FDA’s initial oversight is to assist bringing importers into compliance. This is evidenced by the initial inspection approach, the voluminous outreach conducted by FDA with various stakeholders up to this point, and the amount of educational resources available for FSVP. We are focused on the shared outcome of full, successful implementation of FSVP to ensure the safety of our food supply. FDA has committed to assisting regulating industry with coming into compliance and to communicating with those who are in need of assistance,” Stearn said.