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FDA Guidance for Expediting Entry Review Process

On September 6, 2011 the Food and Drug Administration issued a letter with recommendations to help expedite the entry review process for medical and non-medical radiation-emitting electronic products. In this letter the FDA has noted that Affirmation of Compliance (AofC) codes should be provided at the time of entry to the U.S. and that appropriately submitted AofC codes will not only expedite the admissibility process but will also increase the likelihood that your shipment is not held for further entry review by FDA personnel.

In this letter the FDA has asserted that importers of these products work very closely with their brokers, filers, and other import personnel to verify that the information submitted is accurate and that the correct product codes are entered. The FDA has warned that “inaccurate or inconsistent data may lead to delays”. Furthermore, the AofC codes should be submitted with the relevant qualifier to the FDA and U.S. Customs and Border Protection.

Additionally, CBP regulations compel importers to note whether or not their products comply with federal performance standards. The FDA works with CBP by providing Form  FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, which must be filled out by the importer. Moreover, radiation-emitting devices are also subject to regulation by the Center for Devices and Radiological Health (CDRH) and are subject to federal performance standards. However, there are medical radiation-emitting electronic products that have reporting requirements under 21 CFR 1002 but are not subject to federal performance standards, in which case, Form FDA-2877 is not required.

On the whole, importers, brokers, filers, and other import personnel should take extra care to ensure correct AofC codes that are applicable to medical devices and radiation-emitting electronic products. If you have further questions about importing your medical and non-medical radiation-emitting electronic product, Registrar Corp is available for discussion by phone at +1-757-224-0177or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit:  http://www.registrarcorp.com/fda-updates





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