Under 21 CFR 812, what are the sponsor’s and investigator’s responsibilities for studies that are not exempt from most of the Part 812 requirements?
The majority of the sponsor’s and investigator’s responsibilities in a study of a non-significant risk device are found in section 812.2(b)(1) of the IDE regulation and are summarized below: • Label the device in accordance with 812.5; • 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. • 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 56.109(c). • Comply with the requirements of 812.46 with respect to monitoring investigations; • Maintain the records required under 812.140(b)(4) and (5) and make the reports required under 812.150 (b)(1) through (3) and (5) through (10); • Ensure that participating investigators maintain the records required by 812.140(a)(3)(i) and make the rep
Related Questions
- Under 21 CFR 812, what are the sponsor’s and investigator’s responsibilities for studies that are not exempt from most of the Part 812 requirements?
- What are my responsibilities as the sponsor or the investigator of a study of a significant risk device subject to 21 CFR Part 812?
- What are the Responsibilities of the Sponsor and Principal Investigator?
