Medical Device and Diagnostic Industry (MD+DI)Opinion

FDA's Deregulation of Wellness Devices Is a Slippery Slope

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
JD Supra

There Must Be Some Misunderstanding: FDA Issues a Warning Letter to a Medical Device Company That Made the Wrong Decision on Regulatory Classification

not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system; intended for the purpose of ...
MobiHealthNews

Understanding FDA's new MDDS rule

To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, ...