When you look at the devices created today a good majority of them are using software and let’s say about 5 years ago the opposite was true. We have big “duh” here for those wanting to “fix” the FDA process as they don’t get it or read enough news. Bill Gates has testified every year before Congress and they all nod and say thank you very much and continue to live in the garden of denial. Intel has spent years telling all the same thing! Well our time is about up here and you cant’ do that anymore.
When it comes to writing safe software, you are NOT going to push the developers as you will have problems and deep in my soul this has gone on with coders being pushed to “hurry” up so they can get the product to market. I would be a fool if I said this has not happened. So our dear digital illiterates making laws can keep beating up the agency and asking questions, but not much is going to change. It is what it is. We want safety and sometimes that requires a little more time to not only build the software and hardware but to also test to make sure a product that is being evaluated is “safe”. If you need any more thoughts on this, take a look at this article to where a man died because of faulty device, so how did that get approved? Nobody wanted or wants to be this man.
YOU CAN’T PUSH THE PROCESS AND GUARANTEE OR PARTLY GUARANTEE SAFETY!
The FDA needs in house engineers to work with contracted companies to collaborate with approvals. Now outside of this realm as far as trials go, that’s another matter to where their judgment is best. You might as well start calling our bodies “beta testers” if the push to get devices to market exceeds safety concerns. If you have not caught on yet, then watch this video for some additional clues at to the reality of what’s happening in the world. Work with the FDA and realize the issues they have and support them and cut out the witch hunts.
My last thought on some of this too is that I wish some of the journalists would take some of the drama out of reporting stories like this too, they skew the news and it doesn’t always come out the way it is supposed be with reality and truth but rather written for ratings and sometimes the OMG factors, leave that for Hollywood.
You have digital illiterates making laws that are for “those guys over there” and raising questions about technology they know nothing about and are usually near the bottom of the list with consumer IT knowledge and we find very little participation while the whole world is exploding around them. BD
House Energy and Commerce Committee Democrats sought to blunt Republican attacks on medical device regulations Wednesday by asking medical journal editors to weigh in.
Democrats point out that much of the criticism against the Food and Drug Administration's regulation of medical devices has relied on two studies that were funded by the industry and weren't published in a peer-reviewed journal. The studies argue that medical device approval is slower and more convoluted in the U.S. than in Europe.