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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