CTI. Export in the USA: what “FDA” prescribes
The Food and Drug Administration (FDA) is the U.S. government agency that regulates the products that are marketed in the United States, from food to ethical medicines.
The FDA reports to the U.S. Department of Health and Human Services. The primary objective of the Food and Drug Administration (FDA) is to protect and safeguard the safety and health of citizens by issuing rules and principles of control, regarding the marketing of products, which are investigated according to rigorous processes, including: medicines, foods, supplements and food additives, animal feed and veterinary drugs, medical devices and equipment (including glasses), blood and blood products for transfusion, and cosmetics. Instruments used for control include both pre-marketing assessments and postmarketing monitoring.
For this reason, the first step for any company that intends to export to the United States is FDA registration, which is valid for the calendar year (so regardless of the registration date, it runs out on December 31st).
Until 2012, registration for glasses manufacturers had no cost, but in 2013 the Obama administration put glasses on the same level as medical devices. The cost for 2017 was $ 3,382.00. For 2018, it is rumoured that the total cost will be around $ 4,624.00.
In order to register, companies must appoint a “representative” based in the States, who the FDA will refer to in case of any problems.
At the end of the registration (which can be done online) you will receive your so-called FDA number, which will be specified in the documentation that your US broker will submit to US Customs and allow your good to be cleared.
In addition to the registration of the manufacturer, the recipient must also be registered with the FDA and declare who the manufacturer is.
To date, however, there are some exceptions for authorised practitioners who create or modify a medical device, which is also applied to stores and similar outlets that make direct sales to the final consumer (Direct Sales Under 21 CFR 807.65)
The matter is, however, very complex and intricate, as there are exceptions and inconsistencies depending on the customs officer and the customs through which the goods enter the United States. If you would like any further information, all CTI staff is at your full disposal, including the support of our agent who can also act as an FDA representative.