Authorizations Page

This page contains premarket regulation submission details and supplement numbers of a medical device. The data in this page helps to decide if an applicant has legal rights to market a medical device. A Regulatory Lead or Leader defines the premarket regulation submission details.

Required Roles:

  • Baseline: Leader
  • App-specific: Regulatory Lead

To access this page:

  1. Open the required ASPI. For more information, see Opening a Product Identification.
  2. From the page, click the Authorizations tab.

This topic describes:

This page discusses:

See Also
Creating a Market Authorization Change

Columns

Column Name Description
NameName of the market authorization change object. Click to view its details. For more information, see Opening a Market Authorization Change in the Market Registration User's Guide.
Market Authorization Name of the market authorization object. Click to view its details. For more information, see Opening a Market Authorization in the Market Registration User's Guide.
State State of the market authorization change object.
StatusStatus of the market authorization object.
Regulatory Context The regulatory context that is added to the market authorization.
Notified Body The attribute of regulatory authority that is connected with the regulatory context.
Submission TypeType of market submissions.

It has the following ranges: Premarket Approval, Premarket Notification, De novo Request, Humanitarian Device Exemption, Product Development Protocol, New Drug Application, and Biologics License Application.

Submission Number Number of the submission.
Supplement Number Premarket supplement number of the object.
Expiry Date Number of the supplement.
Certificate Link The link of authorization from the website of authority.
Regulatory Decision The decisions that are added from authority.
Provides the details in a new window.

The following table provides submission number and supplement number formats for various submission types. The values given in the table below are for FDA (USA).

CenterPremarket Submission TypePremarket Submission PrefixSubmission Number FormatSupplement Number FormatGUDID Web Interface Display of Supplement Number
CDRH Premarket Approval(PMA)P1 alpha, 6 digits1-3 digits 001 - system pads zeros to show 3 digits.

011 - system pads zero to show 3 digits

111- no modifications

CDRH Premarket Notification(510(k))KB1 alpha, 6 digits1-3 digits 001 - system pads zeroes to show 3 digits.

011 - system pads zero to show 3 digits

111- no modifications

CDRH De novo Request(DEN) DEN 3 alpha, 6 digits 1-3 digits001 - system pads zeros to show 3 digits.

011 - system pads zero to show 3 digits

111- no modifications

CDRH Humanitarian Device Exemption(HDE) H 1 alpha, 6 digits 1-3 digits001 - system pads zeros to show 3 digits.

011 - system pads zero to show 3 digits

111- no modifications

CDRH Product Development Protocol(PDP) D or N 1 alpha, 6 digits 1-3 digits001 - system pads zeros to show 3 digits.

011 - system pads zero to show 3 digits

111- no modifications

CDRH New Drug Application(NDA) N 1 alpha, 5 or 6 digits1-3 digits001 - system pads zeros to show 3 digits.

011 - system pads zero to show 3 digits

111- no modifications

CBER Premarket Approval(PMA) BP2 alpha, 6 digits 1-4 digits 1 -zeros are not padded

11 -zeros are not padded

111 - zeros are not padded

1111 - no modifications

CBERPremarket Notification(510(k))BK 2 alpha, 6 digits1-4 digits1 -zeros are not padded

11 -zeros are not padded

111 - zeros are not padded

1111 - no modifications

CBER Humanitarian Device Exemption(HDE)BH2 alpha, 6 digits1-4 digits1 -zeros are not padded

11 -zeros are not padded

111 - zeros are not padded

1111 - no modifications

CBER Biologics License Application(BLA)BL2 alpha, 6 digits1-4 digits1 -zeros are not padded

11 -zeros are not padded

111 - zeros are not padded

1111 - no modifications

In the above table, CDRH represents Center for Devices and Radiological Health, and CBER represents Center for Biologics Evaluation and Research.

Note: For CDRH, a supplement number is appended by zeros to show three digits.

Actions and Toolbar Commands

Action Description
Edit Activates edit mode in which you can insert rows and remove newly inserted rows.
Add Existing Adds the existing authorizations.
Raise New Creates an authorization change for the selected authorization change. You can raise an authorization change if the selected authorization change is in the Closed state. When you select the existing MAC to raise a new MAC, the selected MAC is disconnected from the ASPI and a new ASPI is connected to it. The created MAC is also connected with the existing MA.
Remove Removes the market authorization object.
Note: The device identifier must be in the Draft or the Review state. If the MAC is connected with the earlier revision of the ASPI, the selected MAC cannot be deleted.
Delete Deletes the selected authorizations.
Insert new row Inserts a new market authorization row in edit mode
> Insert AboveInserts a new row above the selected row
> Insert BelowInserts a new row below the selected row
Remove inserted row(s)Removes the selected newly inserted row

Promote MAC

The following are the details related to close the MAC that is connected with the context ASPI:

  • When you promote the ASPI to the Approved state, the MAC is auto promoted to the Closed state.
  • When the MAC is approved, the submission and supplement numbers are copied to the MA.
  • The storage conditions that are connected with the MAC is also connected to the MA.
  • The ASPI is not promoted if the promotion of MAC is blocked because of the promotion conditions.
  • The ASPI is promoted in its next state without any changes to the MAC, if the MAC is already promoted to the Closed state.