Why should companies attach importance to FDA registration/certification?
The importance that manufacturers attach to FDA registration/certification directly determines whether the product can be launched in the US market as soon as possible.
The FDA has a regulation for imported products called "automatic detentions," in which potentially problematic imports must be inspected batch by batch (rather than spot check). These products will be released for sale in the United States only after they have passed relevant laboratory tests.
Due to the small number of FDA staff, it is almost impossible to do batch by batch inspection in the face of large specifications and quantity of imported products, so the "spot-check system" is generally adopted. Sampling rate is generally 3~5%, qualified the batch of products released customs clearance; Unqualified trigger "detain mechanism", product listing progress will be greatly blocked.
