FDA Regulation of Mobile Medical Devices and Apps
New Guidance On When Your App Crosses The Medical Device Line
February 10, 2015
Do you know whether your mobile electronic device, app, or web application is regulated by the FDA? Simple devices like smartphones, device lights, cameras, informational apps, and image displays can become regulated medical devices based on how they are promoted. And the burden is on you to know if you are regulated and to comply. At the same time, FDA has issued guidance that excuses a significant segment of applications and devices from regulation, even though they are medical devices. This webinar will review the guidance and provide insight into when your mobile devices, app or web application may or may not require you to register with FDA and comply with medical device regulations.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.