First of all, the company interested in exporting a product to America should determine if the product is a medical device and if its approval is competence of the CDRH.







Companies that want to export medical devices to the United States must obtain FDA CDRH approval


Importers must comply with a set of FDA CDRH procedures to import medical devices in America



 
First of all, the company interested in exporting to America should determine if the product is a medical device and if its approval is competence of the CDRH. 
 
The FDA defines a medical device as:
 
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
 
  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
 
The FDA product code database is a useful instrument to determine a good's class. This may be a tedious and confusing procedure, to speed up procedures companies can seek out ExportUSA's  assistance.
 
 Thanks to our expertise in FDA-related fields we can work with your company to have your your products approved for sale on the American market.
 
The CDRH is responsible even in the case where the device is not medical but emits radiations. Common examples of this are microwave ovens, television sets, devices that make use of radio frequencies and laser beams. 
 
Please see the CDRH website or contact us for more detailed information.