CDS regulation

By Bradley Merrill Thompson 01:23 pm April 11, 2018
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. Since the Medical Device Amendments of 1976, a hallmark of FDA’s regulation of medical devices has been the agency’s risk-based approach....
By MobiHealthNews 01:39 pm April 6, 2018
In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool.  Not all FDA news this quarter was good news. In February Roche’s Accu-Check Connect Diabetes Management App was recalled by the FDA for...
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...
By Brian Dolan 09:49 am June 16, 2014
As MobiHealthNews noted last week in the introduction to our In-Depth report on Apple's Health app feature set, the FDA made a rare move on Wednesday by adding a new description for a type of mobile medical app that it would not regulate as a medical device. The FDA has actually added a total of four such new descriptions to its list in 2014. It just so happened that the latest app description to...