IDE Supplement Checklist



|IDE Supplement Checklist |

|Changes to Investigational Plan |

| |1. Change that eliminates a hazard to subjects or other emergency use |

| |Note: A change to eliminate a hazard to subjects or other emergency use may also prospectively constitute a significant|

| |change to the investigational plan. If applicable, you must also comply with the criteria in section B, below. |

| |Implemented immediately |

| |IRB notified |

| |IDE supplement filed within 5 days |

| |2. Change that significantly affects |

| |Subject rights |

| |Safety or welfare |

| |Soundness of the investigational plan |

| |Data validity or risk/benefit assessment |

| |Note: A significant change to an investigational plan may not be implemented until the IRB has approved the protocol |

| |change and the IDE supplement has been submitted to FDA. |

| |Submit proposed change(s) to IRB |

| |IRB approval received |

| |IDE supplement filed with FDA |

| |30 days or FDA approval letter |

| |3. Changes permitting a 5-day notice of IDE change |

| |Note: Certain changes maybe made and implemented in an investigational plan if the changes satisfy the criteria below |

| |and FDA is apprised of the changes in a 5-Day Notice of IDE Change. The Notice of IDE Change must be filed with FDA |

| |within 5 days of the date when the changes are implemented. These changes do not require prior FDA approval for |

| |implementation. |

| |Note: For changes, FDA requires the submission of credible supporting information, which is defined as data generated |

| |from design control procedures, preclinical/animal testing, peer reviewed published literature, or other reliable |

| |information such as clinical information gathered during a study or marketing. |

| |A. Developmental or manufacturing changes in the device if |

| |Not a significant design change |

| |Not a change in principle of operation |

| |Response to new information acquired during the investigation |

| |Summary of relevant information on which change was based |

| |Description of change, cross-referenced with original IDE submission |

| |Statement that under design controls, no new risks were identified |

| |Any other credible information to support the change. |

| |B. Protocol change if that change does NOT significantly affect: |

| |Subject rights, safety or welfare |

| |Soundness of the investigational plan |

| |Data validity or risk/benefit assessment |

| |Description of the change, cross-referenced with original IDE submission |

| |Assessment supporting determination that change does not affect: |

| |Study design |

| |Statistical analysis |

| |Rights, safety or welfare or subjects |

| |4. New Investigative Site Added |

| |IRB approval of new site |

| |Certification of IRB approval to FDA for any site not included in original IDE |

| |Criteria for waiver for additional investigative sites met? (See IDE Manual, section 4) |

| Format |

| |Use paper with nominal dimensions of 8 ½ by 11 inches |

| |Use at least a 1½ inch wide left margin to allow for binding into jackets |

| |Use 3-hole punched paper to allow for binding into jackets |

| |If submission exceeds 2-inch thickness, separate into volumes, identify volume number |

| |Identify the FDA-assigned IDE document number |

| |Identify type of submission (Example: IDE Supplement, Response to FDA Letter; Addition of New Site) |

| |Note: Only the IDE Sponsor may amend, supplement, or submit reports to the IDE, unless written authorization is |

| |provided. |

| |All copies of each submission must be identical |

| |Note: Do not combine submissions |

| |Provide a detailed table of contents |

| |Sequentially number the pages, and use tabs to identify each section |

| |State on the outside wrapper what the submission is: |

| |(Examples: Supplemental IDE Application, IDE Correspondence) |

| |All submissions, in triplicate, should be addressed to: |

| |Food and Drug Administration |

| |Center for Devices and Radiological Health |

| |Document Mail Center (HFZ-401) |

| |9200 Corporate Blvd. |

| |Rockville, MD 20850 |

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