Class 1 devices are intended for devices that require general controls by the FDA. At home blood pressure monitors are considered a class 1 device. Although they are not intended to diagnose, people rely on these monitors to make sure their blood pressure is at safe normal levels between doctor visits. If a monitor was not regulated by the FDA it…[Read more]

As stated in Dr. Simon’s lecture, leadership is 30% academic and intelligence based and 70% interpersonal skills based. While I do not have experience in industry, I spent this entire past fall interviewing with medical device and pharmaceutical companies. I was pre-medicine all the way up until the end of my junior year when I realized my passion…[Read more]

In response to my last post, I found sponsor responsibilities after the significant risk (SR) versus non-significant risk (NSR) determination.

If the IRB decides a study is SR, the sponsor must:

Submit IDE to FDA
Not begin the study until the FDA approves the IDE and the IRB approves the study
Comply with IDE regulations and informed…[Read more]

I think to add to the discussion of significant risk (SR) versus non-significant risk (NSR) it is useful to read about the considerations that the FDA suggests to the IRB for SR and NSR determination. I got the below information from a guideline from the FDA. Below are the three main considerations listed in the document.

1. Risk determination is…[Read more]