On the whole, class I devices are characterized by the low level of risk involved in their use. This makes the procedure quicker and simpler than that required for higher classes. 

 

Class I devices are eligible for:

 

 

ExportUSA can help a company verify whether its product is eligible for exemption.

 

If the product does not require a 510(k) pre-marketing notification, it must still observe all other FDA specifications. Labeling requirements are especially important. ExportUSA offers consulting services for companies interested in learning more about FDA requirements for medical devices.

 

FDA registration is required for all companies producing and selling medical devices in the United States. 

Depending on what kind of activities the company carries out, it may be exempt from paying the annual registration fee and declaring or describing the items it plans to sell.

 

Finally, once the product enters the market, the registered firm will be responsibile for meeting the  Good Manufacturing Practice (GMP) requirements of the Quality System regulation. The latter comprises labeling, design, packing and manufacturing of the item. It also requires that a Medical Device Reporting system be set up to facilitate reporting of malfunctioning devices.