Reports

The following reports are required by the sponsor under §812.150. All reports to FDA should be identified as IDE Supplements and submitted in triplicate.

Unanticipated Adverse Device Effects

The sponsor must report the results of an evaluation of an unanticipated adverse device effect to FDA and all reviewing IRBs and investigators within 10 working days after the sponsor first receives notice of the adverse effect.

Withdrawal of IRB Approval

The sponsor must notify FDA and all reviewing IRBs and participating investigators of the withdrawal of IRB approval of an investigation (or any part of an investigation) within 5 working days of receipt of the withdrawal of approval.

Withdrawal of FDA Approval

The sponsor must notify all reviewing IRBs and participating investigators of any withdrawal of FDA approval within 5 working days after receipt of the notice.

Current List of Investigators

Every six months the sponsor must submit to FDA a current list of the names and addresses of all investigators participating in a significant risk device investigation.

Progress Reports (or Annual Reports)

At regular intervals and at least yearly, the sponsor must provide progress reports to all reviewing IRBs. For a significant risk device, the sponsor must also submit the progress report to FDA.  A suggested format is provided below.

Recalls and Device Disposition

The sponsor must notify FDA and all reviewing IRB’s of any request that an investigator return, repair, or dispose of any unit of an investigational device. The notice must be made within 30 working days after the request is made and must state why the request was made.

Final Report

For a significant risk device, the sponsor must notify FDA and all reviewing IRBs within 30 working days of the completion or termination of the investigation. The sponsor must also submit a final report to FDA and all reviewing IRBs and participating investigators within 6 months after the completion or termination of the investigation. A suggested format is provided below.  For a nonsignificant risk device, the sponsor must submit a final report to all reviewing IRBs within 6 months after completion or termination.

Informed consent

Sponsors must submit a copy of any report by an investigator of the use of a device without first obtaining informed consent. The report must be made to FDA within 5 working days after receipt of the notice of such use.

Significant Risk Device Determination

If an IRB determines that the device is a significant risk device and not a nonsignificant risk device as the sponsor had proposed to the IRB, a report must be submitted to FDA within 5 working days after the sponsor learns of the IRB’s determination.

Other Reports

The sponsor must provide accurate, complete, and current information about any aspect of the investigation upon request from the reviewing IRB or FDA.

Suggested Format For IDE Progress Report

1. Basic Elements





• IDE Number
• Device name and indication(s) for use
• Sponsor's name, address, phone number, and fax
• Contact person
  


2. Study Progress
   (Data from beginning of the study should be reported, unless otherwise indicated.)





• Brief summary of the study progress in relation to the investigational plan
• Number of investigators/investigational sites (attach list of investigators)
• Number of subjects enrolled (by indication or model)
• Number of devices shipped
• Brief summary of results
• Summary of anticipated and unanticipated adverse effects
• Description of any deviations from the investigational plan by investigators (since last progress report)




3. Risk Analysis




• Summary of any new adverse information (since the last progress report) that may affect the risk analysis; this includes preclinical data, animal studies, foreign data, clinical studies, etc.
• Reprints of any articles published from data collected from this study
• New risk analysis, if necessary, based on new information and on study progress


4. Other Changes


• Summary of any changes in manufacturing practices and quality control (including changes not reported in a supplemental application)
• Summary of all changes in the investigational plan not required to be submitted in a supplemental application


5. Future Plans


• Progress toward product approval, with projected date of PMA or 510(k) submission
• Any plans to change the investigation, e.g., to expand the study size or indications, to discontinue portions of the investigation or to change manufacturing practices (NOTE: Actual proposals for these changes should be made in a separate supplemental application).

Suggested Format for IDE Final Report

1. Basic Elements


• IDE Number
• Device name and indication for use
• Sponsor's name, address, phone number, and fax number
• Contact person


2. Study Progress
   (Data from beginning of the study should be reported, unless otherwise indicated.)


• Brief summary of study progress in relation to investigational plan
• Number of investigators/investigational sites (attach list of investigators)
• Number of subjects enrolled (by indication or model)
• Number of devices shipped
• Disposition of all devices shipped
• Brief summary of results
• Summary of anticipated and unanticipated adverse effects
• Description of any deviations from the investigational plan by investigators (since last progress report)


3. Risk Analysis


• Summary of any new adverse information (since last progress report) that may affect the risk analysis; this includes preclinical data, animal studies, foreign data, clinical studies, etc.
• Reprints of any articles published from data collected from this study


4. Other Changes


• Summary of any changes in manufacturing practices and quality control (including changes not reported in a supplemental application)
• Summary of all changes in investigational plan not required to be submitted in a supplemental application


5. Marketing Application or Future Plans


• Progress toward product approval, with date (or projected date) of PMA or 510(k) submission; or indication that marketing of device is not planned.
• Any plans to submit another IDE application for this device or a modification of this device.

The investigator must provide the following reports in a timely manner under §812.150.

The investigator must submit to the sponsor and the reviewing IRB a report of any unanticipated adverse device effect as soon as possible but no later than 10 working days after the investigator first learns of the effect.

The investigator must report to the sponsor a withdrawal of approval of the reviewing IRB within 5 working days.

The investigator must submit progress reports to the sponsor, the monitor, and the reviewing IRB at regular intervals but no less than on a yearly basis.

The investigator must notify the sponsor and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. The notice must be provided as soon as possible but no later than 5 working days after the emergency occurred. If it is not an emergency, prior approval from the sponsor is required for changes in or deviations from the investigational plan. If the change or deviation may affect the scientific soundness of the investigational plan or the rights, safety or welfare of the subject, the sponsor is required to obtain prior IRB approval and also to obtain FDA approval for a significant risk device investigation by submitting a supplemental application.

If an investigator uses a device without obtaining informed consent, the investigator must report the used to the sponsor and to the reviewing IRB within 5 working days after the use occurs.

The investigator must submit a final report to the sponsor and to the reviewing IRB within 3 months after termination or completion of the investigation.

The investigator must provide accurate, complete, and current information about any aspect of the investigation upon request from the reviewing IRB or FDA.

Investigator Annual Progress Reports and Final Reports

The IDE regulations do not specify the content of the annual progress or final reports. Therefore, the contents of these reports may largely be dictated by the sponsor. With respect to reports to the IRB, the IRB itself may specify what information it wishes to be included in these reports. Because FDA does require the information listed below, it is suggested that, at a minimum, the annual progress and final reports to the sponsor and the IRB include the following items:

1. IDE number
2. Device name
3. Indications for use
4. Brief summary of study progress in relation to investigational plan
5. Number of subjects enrolled
6. Number of devices received, used, and, in the final report, the final disposition of unused devices
7. Brief summary of results and, in the final report, conclusions
8. Summary of anticipated and unanticipated adverse device effects
9. Description of any deviations from investigational plan
10. Reprints of any articles published by the investigator in relation to the study