5. Action on a 30-Day Notice, 135-Day PMA Supplement, or 75-Day HDE Supplement
If the change qualifies for a 30-day notice and you have submitted complete information in the 30-day notice to FDA, you may distribute the device 30 days after the date on which FDA received the notice, unless FDA notifies you with those 30 days that the notice is inadequate.
However, if the information you have submitted is not adequate, within 30 days of receipt FDA will inform you in writing that a 135-day PMA supplement (or for HDE holders, a 75-day HDE supplement) is needed and shall describe additional information or action that is required for acceptance of that change. 21 CFR 814.39(f), 814.108.
If no action occurs within 30 days of receipt of your 30-day notice and payment of the user fee, you may distribute the device without further action from FDA.12
From the FDA website
