If the product is indeed a medical device then classification is the first step towards obtaining CDRH approval.







To obtain FDA CDRH approval, exporters and manufacturers must find what regulatory class the medical device belongs to


ExportUSA can help companies classify the medical device they intend to sell in America



 
If the product is indeed a medical device then classification is the first step towards obtaining CDRH approval. 
 
As previously mentioned, CDRH requirements for approval depend on the regulatory class of the device. 
 
Thus, it is extremely important that the device be classified properly. In order to identify the product's regulatory class one can make use of:
 
  1. Title 21 of the Code of Federal Regulation (CFR) parts 862-892. This is the main classification instrument as it lists over 1700 devices, specifying the class and requirements needed for their approval.
  2. Another method is to use the product code database.
 
ExportUSA offers consulting services to companies that need help determining their product's regulatory class.