The New Details About The FDA Regulation Of mHealth Apps
Since the beginning of this year, there have been clues that the FDA will be heading toward clarification of the complex regulatory issues posed by mobile health devices and software. We have previously reported on testimony and public comments by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH) alluding to coming guidelines.
Today, the FDA finally released a detailed draft guidance of how it intends to regulate this rapidly exploding sector of mobile medical devices and software.
This is what the Emergo group, regulatory compliance consultants, has gleaned from today’s FDA press release: Read more »
*This blog post was originally published at iMedicalApps*
