The majority of the sponsor’s and investigator’s responsibilities in a study of a nonsignificant risk device are found in 21 CFR 812.2(b)(1) of the IDE regulation and are summarized below:
a. Label the device in accordance with 21 CFR 812.5;
b. Obtain IRB approval of the investigation after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device, and maintain such approval.
c. Ensure that each investigator participating in an investigation of the device obtains from each subject under the investigator’s care, informed consent under part 50 and documents it, unless documentation is waived by an IRB under 21 CFR 56.109(c).
d. Comply with the requirements of 21 CFR 812.46 with respect to monitoring investigations;
e. 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) through (3) and (5) through (10);
f. Ensure that participating investigators maintain the records required by 21 CFR 812.140(a)(3)(i) and make the reports required under 21 CFR 812.150(a)(1), (2), (5), and (7);
g. Comply with the prohibitions in 21 CFR 812.7 against promotion and other practices.
All studies should have a written protocol as described in 21 CFR 812.25(b) and a risk analysis as described in 21 CFR 812.25(c), regardless of the status of the study under 21 CFR Part 812.
All sites participating in the study should use identical copies of the protocol and receive protocol amendments simultaneously so that data is collected in a consistent manner. Data collected from different sites otherwise may not be able to be pooled in the final analysis due to inconsistencies in how it was collected. We recommend that protocols describe the study objectives, design, methodology, subject populations, types of specimens, data to be collected and planned data analysis. (See also Data Considerations, Section VI, of this guidance).
