Newsletter - December 15, 2022
FDA’s Digital Health Navigator
The regulation of medical software by FDA, whether it is used standalone or as a component of another device, is rife with confusion. FDA released an online tool this week that attempts to answer the most common questions from software-as-medical device (SaMD) developers. SaMD products come in several forms. Read More
Clinical Trials Cannot be Done Without an FDA-Cleared IND
It should be a moot point that clinical trials cannot be conducted without filing an IND application with the FDA and waiting for the FDA clearance prior to initiating the trial in patients. It also should be a moot point that IRB approval alone is not sufficient to initiate clinical trials with drugs and biologics...Read More
FDA’s Digital Health Navigator
The regulation of medical software by FDA, whether it is used standalone or as a component of another device, is rife with confusion. FDA released an online tool this week that attempts to answer the most common questions from software-as-medical device (SaMD) developers. SaMD products come in several forms. Read More
Clinical Trials Cannot be Done Without an FDA-Cleared IND
It should be a moot point that clinical trials cannot be conducted without filing an IND application with the FDA and waiting for the FDA clearance prior to initiating the trial in patients. It also should be a moot point that IRB approval alone is not sufficient to initiate clinical trials with drugs and biologics...Read More
