FDA CDS apps

By MHN Staff 10:09 am October 8, 2015
By Bradley Merrill Thompson If I invented an unprecedented mobile technology for treating tennis elbow, the law would require me to do substantial and expensive clinical trials before bringing it to market. In my last post, I argued that the FDA regulatory system is structurally biased against new technology, including novel software, even if it is low risk.  By law, any medical device that is...