About Grace Period

Grace period is the time allocated by a regulatory authority for DI (Device Identification) modifications after a DI object is published to GUDID(Global Unique Device Identification Database). The grace period starts a day after the DI object is published and ends after specific calendar days as defined by the regulatory authority.

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Information Page

You can modify some DI attributes during the grace period. You can use the Revise command to modify the DI attributes. The attributes that can be modified for the revision of a DI object is given in the page object (xml). Your administrator can customize the xml according to the rules of the country. For more information, see Page Object for Grace Period in the Device Identification Administration Guide.

If the package product attribute of a DI object is revised, the new revision of the package product gets associated to the revised DI, and the frozen package product continues to be connected to the previous DI revision. When a DI object is revised, the attributes such as contact information, market authorization, and storage conditions have to be copied to the revised DI. You can use the Clone command in the page toolbar for this. For a DI revision, you can clone all these attributes only once.

The first revised DI is with revision one and on revising it, a new DI is created with revision two and so on. Only a Product Manager can revise a DI. When the new DI revision is published, the previous DI revision moves to the Superseded state.

The revised DI object needs to be resubmitted to the regulatory authority. The authority accepts the revised DI if the changes made are according to the rules that are given in its website.

To accommodate grace period changes, the Superseded lifecycle state is added for DI objects, and the Frozen lifecycle state is added for the package products lifecycle states. For more details, see DI objects lifecycle and Package product lifecycle.

The Grace Period capability with the below changes

  • Earlier the value of model number for grace period evaluation is referred from device identification but now the value of model number is referred from a model.
  • The values for the registration number and supplement number are evaluated from a market authorization change.
  • The title of trade names is used for a grace period evaluation as the name of a brand or a marketing for the context device identification.
  • The Grace period is applicable only for the device identifications that are created for the USA.
  • However, grace period can be applied if common information of DI is modified that have impact on DI submitted for USA.
  • The information about grace period is displayed when you hover over the name of DI that is created for USA from the Regulatory category of a product and the DI home page.
  • In the Properties page of a DI, the Grace Period is displayed only DIs that are created for the specific to USA.