Procedure for Submitting Device Identification to Regulatory Authority

You can view the list of device identification objects created for medical device products, add the necessary information to the device identification object, and submit it to the regulatory authority.

Before you begin:
  1. Promote the device identification object to the Review state. If you need an additional review, set the value of the Needs Review field in the Device Information page to Yes.
  2. Add the necessary information to the Device Information page, Device Status page, and the Device Characteristics page. See Modifying Device Identification Details, Modifying Device Status Details, and Modifying Device Characteristics Details.
  3. Optional: Create a secondary device identifier (DI). See Creating a Secondary Device Identifier.
  4. Create a package DI. See Creating a Package Device Identifier.
  5. Create or add a contact. See Contacts.
  6. Optional: Add market authorization details. See Creating a Market Authorization Change.
    Note: You must add the market authorization details if the device:
    • is not exempt from premarket submission.
    • is not a medical procedure kit.
    • contains human cell, tissue, or a cell or tissue-based product.
  7. Optional: Add measurement details. See Adding Clinically Relevant Size Details.
  8. Add storage and handling information. See Adding Storage Condition Details.
  9. Promote the device identification object to the Approved state.
    Note: If a route object exists between the Review and the Approved states, ensure that it is completed.
  10. Accept the device identification object to submit it to the regulatory authority.
    Note: To perform this action, you must be:
    • a Regulatory Lead.
    • on the Device Identification Home Page.

    If required, the object owner can transfer the device identification object to a Regulatory Lead to submit to the regulatory authority. See Transferring a Device Identification.

  11. Submit the device identification details to the regulatory authority. See Submitting Device Identification to Regulatory Authority Through AS2 Gateway.