Industry Applauds FDA Draft Guidance On Mobile Medical Apps
This article was originally published in The Gray Sheet
Executive Summary
The medical device and software industries voiced support last week for a July 19 FDA draft guidance that helps clarify the types of mobile software applications that would face FDA regulation.
You may also be interested in...
FDA’s Mobile Health Guidance Removes Risk For Investors
Investors and their limited partners really don’t like risk, especially not the kind due to uncertainty. Now, for developers of mobile health applications and their investors, at least one risk has been taken off the table: regulatory uncertainty. On September 23, the FDA published the much-anticipated final guidance on mobile medical apps.
FDA Emphasizes “Deregulatory” Efforts In Mobile Medical Apps Final Guidance
In a long-awaited final guidance, FDA affirmed its plan to practice enforcement discretion for most mobile medical apps, except those applications that present the same risks as conventional FDA-regulated devices. Some digital health stakeholders praised the guidance, while others wished FDA had waited.
FDA Emphasizes “Deregulatory” Efforts In Mobile Medical Apps Final Guidance
In a long-awaited final guidance, FDA affirmed its plan to practice enforcement discretion for most mobile medical apps, except those applications that present the same risks as conventional FDA-regulated devices. Some digital health stakeholders praised the guidance, while others wished FDA has waited.