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This is the first step in determining the best way to ensure your products’ compliance.
Product AnalysisIt’s the number issued by the FDA following the company’s registration.
What is the FDA number?No. The FDA does not certify any products, nor issue permits or authorizations.
Does the FDA issue certifications / authorizations for products imported to the US?The production process also affects the compliance procedure.
Review of Production ProcessThis is the second step in determining if there are any inadmissible ingredients.
Analysis of IngredientsNo. The registration must be renewed every two years [by 12/31 of even-numbered years].
Is FDA registration a one-off?No. American regulations are completely different.
Can I use the same nutrition fact label in the US as I do in Italy?This is the final step in determining a product’s admissibility in the US market.
Review of Colorants and PreservativesFor medical devices this is the first step in ensuring compliance: understanding how the product is classified according to the classification rules dictated by the FDA.
ClassificationRegistration usually takes between two and three working days.
How long does it take to register with the FDA?No. Registration with the FDA is not mandatory for companies that produce cosmetics.
If I want to sell cosmetics in the US, is it mandatory that I register my company with the FDA?For cosmetics, this is the most critical step in ensuring a product’s compliance: it’s necessary in order to avoid the product being classified as a medication rather than a cosmetic.
Review of the ClaimNo. Only the company must register. Products don’t get registered, but they must comply with standards.
I sell food products. Do I have to register them with the FDA?