Device Listing

All of devices that need to be sold in the US must be reported to the FDA prior to sale.
Maytal can:
  • assist the company in evaluating the classification and selection of the appropriate product codes for medical devices, if they register class I products for the first time. For other classes, the Product code is already identified by FDA (eg. 510 (k))
  • assist the company to carry out the appropriate groupings to reduce the registration burden and to correctly identify the proprietary names to be recorded in line with the company's commercial documentation
  • if requested, assist the company in allocation of the UDI code required for any product to be sold in the USA by 2020
  • Complete the registration details required by the FDA by registering the devices on the FDA website