How do clinical trials work for a medical device in the USA?
ฝัง
- เผยแพร่เมื่อ 18 ส.ค. 2022
- One of the subscribers on our TH-cam channel requested this video topic. They submitted an email requesting that we explain the guidelines for launching a medical device clinical study in the USA. They also requested an explanation of the timeline and the documentation required. We won’t have time to get into the details of an IDE submission, but we will provide links in the video’s description for where to find the details of what is required for an IDE for a pivotal study, where to find CDRH Learn presentations specific to clinical studies, and where to find information about Early Feasibility Studies (EFS). We will also discuss other types of studies that do not require an IDE.
CDRH Learn ➤ www.fda.gov/training-and-cont...
IDE Guidance ➤ www.fda.gov/medical-devices/i...
IDE Guidance for EFS & FIH Studies ➤ www.fda.gov/media/81784/download
ISO 14155:2020 Standard ➤ www.evs.ee/en/evs-en-iso-1415...
We also sell a clinical procedure (SYS-009) that provides high-level guidance on the steps required for a clinical study ➤ medicaldeviceacademy.com/clin... - วิทยาศาสตร์และเทคโนโลยี
Thank you for the video! You have a really effective way of communicating your ideas.
Thank you for the positive feedback. Suggestions for future topics are always welcome.
Thank you, Rob, this video was very helpful! During your discussion on statistical comparison, you mentioned superior, non-inferior and equivalent analysis. Can you describe how a superior analysis can be used if US submissions are based on substantial equivalence? Thanks!
Superiority is usually not used for 510(k) submissions. Typically it would only be used for a De Novo, HDE, or PMA.
Hey! I was wondering if you could talk about how the breakthrough process work for a PMA.
Next Friday, October 6, we will have a live-streaming video on the breakthrough device designation and I will add information about PMAs.