What are my responsibilities as the sponsor or the investigator of a study of a significant risk device subject to 21 CFR Part 812?
The sponsor’s responsibilities for significant risk device investigations are described in Appendix 3 of this guidance. This information is also included as an enclosure in all IDE approval letters. The investigator’s responsibilities for significant risk device investigations are described in Appendix 4 of this guidance. This information is also included as an enclosure in all IDE approval letters.
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 is the difference between a significant risk (SR) device and a non-significant risk (NSR) device?
