Required Sponsor Reports to a FDA-Accepted IDE Application[1]
- Unanticipated AdverseDevice Effects
- Withdrawal of IRB Approval
III.Current Investigator List
IV.Progress Reports
V.Notice of Device Recall or Deposition
VI.Final Report
- Failure to Obtain Informed Consent
- Unexpected Significant Risk Device Determination
- Other
A sponsor shall prepare and submit the following complete, accurate and timely reports to the FDA for inclusion in the respective FDA-accepted IDE application: (See also Sponsor Responsibilities: Significant Risk Device Studies)
I.Unanticipated Adverse Device Effects[2]
A. A sponsor who conducts an evaluation of an unanticipated adverse device effect (see Sponsor Responsibilities) shall report the results of such evaluation to the FDA within 10 working days after the sponsor first receives notice of the effect.
B.Subsequent to the initial report of an unanticipated adverse device effect, the sponsor shall submit additional reports concerning the effect as per FDA request(s).
II.Withdrawal of IRB Approval
The sponsor shall notify the FDA within 5 working days of the sponsor’s receipt of notice of the withdrawal of approval of a device investigation or part of a device investigation by a reviewing IRB.
III.Current Investigator List
A.The sponsor shall submit to the FDA, at 6 month intervals, a current list of the names and addresses of all investigators participating in the investigation(s) of the device.
B.The sponsor shall submit the first such listing of current investigators at 6 months after FDA acceptance of the IDE application.
IV.Progress Reports
For a significant risk device, the sponsor shall submit progress reports at regular intervals, and at least yearly, to the FDA.
V.Notice of Device Recall or Deposition
The sponsor shall notify the FDA within 30 working days of any request made by the sponsor that an investigator return, repair, or otherwise dispose of any units of an investigational device.
VI.Final Report
For a significant risk device, the sponsor shall notify the FDA with 30 working days of the completion or termination of the investigation and shall submit a final report to the FDA within 6 months after completion or termination.
VII.Failure to Obtain Informed Consent
The sponsor shall submit to FDA, within 5 working days of receipt by the sponsor, a copy of any report by an investigator (see Investigator Responsibilities) of the use of an investigational device without obtaining informed consent.
VIII.Unexpected Significant Risk Device Determination
If an investigational device study that was submitted initially as a non-significant device study is determined by a reviewing IRB to be a significant risk device study, the sponsor shall submit to the FDA a report of the IRB’s determination within 5 working days after the sponsor first learns of this determination.
IX.Other
The sponsor shall, upon request by the FDA, provide accurate, complete, and current information about any aspect of the device investigation.
1
[1]21 CFR Sec. 812.150(b)
[2] An unanticipated adverse device effect is defined (21 CFR Sec. 812.3(m)) a “any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or IDE application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.”