Studies of non-significant risk devices are subject to abbreviated IDE requirements. An IDE submission to the FDA is not required under the abbreviated requirements, but the requirements for labeling, IRB approval, informed consent, monitoring, records, reports and promotional practices contained in FDA regulations still apply (21 CFR 812.2(b)).
Requirements under abbreviated IDE:
- The sponsor will label the device in accordance with 21 CFR 812.5.
- The sponsor will obtain and maintain IRB approval throughout the investigation as a nonsignificant risk device.
- The sponsor will ensure that each investigator participating in an investigation of the device obtains and documents consent from each subject under the investigator’s care according to 21 CFR 50, unless documentation is waived by an IRB.
- The sponsor will comply with the requirements of 21 CFR 812.46 with respect to monitoring investigations.
- The sponsor will maintain the records required under 21 CFR 812.140(b) (4) and (5) and make the reports required under 21 CFR 812.150(b) (1) – (3) and (5) – (10); The sponsor will ensure that participating investigators will maintain the records required by 21 CFR 812.140(a)(3)(i) and make the reports required under 812.150(a) (1), (2), (5), and (7).
- The sponsor will comply with the prohibitions in 21 CFR 812.7 against promotion and other practices.
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