The Small Business Decision number is used by FDA to confirm that you have been qualified as a small business and may receive the appropriate user fee reduction or waiver when you submit an application that requires a user fee (as described at the FDA MDUFA User Fees website8). You should use your Small Business Decision number to document that you have qualified as a small business. You should include your Small Business Decision number when you submit a Medical Device User Fee Cover Sheet, which is available from the FDA User Fee System.
