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The assessment of whether or not a device study presents a NSR is initially made by the sponsor. If the sponsor considers that a study is NSR, the sponsor provides the reviewing IRB an explanation of its determination and any other information that may assist the IRB in evaluating the risk of the study. The sponsor should provide the IRB with a description of the device, reports of prior investigations with the device, the proposed investigational plan, a description of patient selection criteria and monitoring procedures, as well as any other information that the IRB deems necessary to make its decision. The sponsor should inform the IRB whether other IRBs have reviewed the proposed study and what determination was made. The sponsor must inform the IRB of the Agency's assessment of the device's risk if such an assessment has been made. The IRB may also consult with FDA for its opinion regarding its NSR/SR determination.
The IRB may agree or disagree with the sponsor's initial NSR assessment. If the IRB agrees with the sponsor's initial NSR assessment and approves the study, the study may begin without submission of an IDE application to FDA. If the IRB disagrees, the sponsor should notify FDA that an SR determination has been made. The study can be conducted as an SR investigation following FDA approval of an IDE application.
For nonsignificant risk devices, the investigator must maintain the following:
- The name and intended use of the device (type and quantity of the device, the dates of its receipt, and the batch number or code mark).
- A brief explanation of why the device is not a significant risk.
- The name and address of each investigator and the names of all persons who received, used, or disposed of each device.
- Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of
- A statement of the extent to which Good Manufacturing Practice (GMP) regulations will be followed in manufacturing the device (see also 21 CFR 820).