I completed a clinical trial that studied an investigational product (drug, biological product, or device that is not initially approved, licensed, or cleared by the FDA). There is no intent to seek approval, clearance, or licensure of the product by the FDA (for example, development of the investigational product has been terminated). How do I indicate that results need not be submitted for this trial?

The Responsible Party may Certify Initial Approval in the PRS. This indicates that the clinical trial was completed before a drug, biological product, or device studied in the trial was initially approved, licensed, or cleared by the FDA for any use.