For verification, it’s important to note that tests aren’t the only acceptable verification activities; a company can also utilize inspections and analyses for their requirements, which can sometimes be cheaper and/or less time-consuming than tests. Some examples of these alternate verifications include: “thermal analysis of an assembly to assure…[Read more]

My follow up question is, do strict policies stunt medical innovation and economic growth?

This is a really good follow up question to think about. I believe strict policies do stunt medical innovation and economic growth, but it is necessary. We as a society most definitely want to prevent tragedies like the Thalidomide one if we can do so (which…[Read more]

I find this point about the Fitbit app very interesting. I myself own a Fitbit and the associated app, and this app allows you to monitor various things such as sleep patterns, physical activity, and even heart rate (if your model has that hardware). It gives the user some tools to better one’s lifestyle, similar to the app the OP posted about.…[Read more]

I agree with gingeranderson, if we’re hypothetically talking about getting technology to the point where artificially grown organs are nearly indistinguishable from human organs, then it would fall under the responsibility of CBER to regulate these organs. However, I believe before we get to this end goal the government will have expanded this…[Read more]

It seems that a recent lawsuit about power morcellators in 2014 has brought up this issue again. Dr. Amy Reed underwent surgery to remove uterine fibroids using laparoscopic power morcellation, an otherwise routine hysterectomy. In this process, a tool is inserted through a small incision in order to mince an internal structure so it can be…[Read more]