Creating a Market Authorization Change

You can create a market authorization change object and add the premarket regulation submission details and supplement numbers for 510(k), PMA, PDP, HDE, BLA, DEN, and NDA. You can create a market authorization object if the medical device product contains human tissue, is not a kit product, or is not exempt from premarket submission.

Required Roles:

  • Baseline: Leader
  • App-specific: Regulatory Lead

Before you begin:
  1. From the page toolbar, click Edit.
  2. From the page toolbar, click Insert new row.
    An empty row appears.
  3. Enter the following details.
    Column Name Description
    Regulatory Context lick to search for and select a regulatory context.
    Submission Type Select the submission type.
    Submission Number Type the submission number. he number must either start with P, KB, H, D, BP, BK, BH, BL, and DEN followed by 6 digits or with N followed by 5 or 6 digits.
    Supplement NumberType the supplement number. The number must have 3 or 4 digits.
  4. Click Save.
    The details are saved.
  5. Click Disable Edit to exit edit mode.

The market authorization change object is created.