Reports
Sponsor 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 IRBs 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 IRBs
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
- Basic Elements
- IDE Number
- Device name and indication(s) for use
- Sponsor's name, address, phone number, and fax
- Contact person
- 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)
- 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
- 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
- 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
- Basic Elements
- IDE Number
- Device name and indication for use
- Sponsor's name, address, phone number, and fax number
- Contact person
- 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)
- 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
- 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
- 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.
Investigator Reports
The investigator must provide the following reports in a timely
manner under §812.150.
Unanticipated Adverse Device Effects
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.
Withdrawal of IRB Approval
The investigator must report to the sponsor a withdrawal of approval of the reviewing
IRB within 5 working days.
Progress Reports
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.
Deviations from the Investigational Plan
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.
Informed Consent
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.
Final Report
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.
Other Reports
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:
- IDE number
- Device name
- Indications for use
- Brief summary of study progress in relation to investigational plan
- Number of subjects enrolled
- Number of devices received, used, and, in the final report, the final disposition of
unused devices
- Brief summary of results and, in the final report, conclusions
- Summary of anticipated and unanticipated adverse device effects
- Description of any deviations from investigational plan
- Reprints of any articles published by the investigator in relation to the study
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