Determine if your medical app will require FDA regulation.
Tag: Regulations
FCC & FDA moving connected health forward by establishing wireless medical test beds
Public meeting set to discuss plans to establish “test beds” to trial emerging connected health devices & systems
The clinicians’ guide to FDA regulations on mobile medical apps
iMedicalApps’ breaks down the recent final guidance from the FDA on how it intends to regulate mobile medical apps.
With both FTC and FDA going after medical apps, recent study identifies other apps for scrutiny
A recent study highlights other apps that may garner regulatory scrutiny.
FCC Launches New Era for Development of Wireless Medical Devices
[Ed: We are pleased to present this in-depth report on the recent regulatory changes announced by the FCC related to mHealth research by experienced FCC attorney Robert Primosch. By: Robert D. Primosch, Esq Partner, Wilkinson Barker Knauer, LLP. The enormous growth of medical devices that use wireless telecommunications technology – and the corresponding need to […]