Draft guidance: Review of first-in-human high-risk implantable or cardiac invasive medical device clinical trials and Investigator’s brochures for medical device clinical trials

We asked for feedback on two draft guidance web pages we developed to support the changes to TGA oversight of clinical trials of medical devices. The pages describe the review process for first-in-human high-risk implantable or cardiac invasive medical device clinical trials and the expectations for Investigator’s brochures for medical device clinical trials.

We received two submissions, with respondents suggesting some minor points of clarification. 

We thank respondents for providing their feedback, which has been reviewed and incorporated into the draft guidance. The guidance will soon be published on the TGA website.