The US Food and Drug Administration has begun to flex their regulatory muscles with regard to mobile medical devices.
Tag: FDA medical app regulation
This session discussed the fragmentation of the healhcare industry and the challenges that arise from classifying an app as an accessory for FDA regulation.
The second session of the day focuses on the level of oversight and the proposed approach to utilize the current device classifications and oversight controls.
This post is part of iMedicalApps coverage of the FDA meeting regarding its draft guidance of mobile medical apps. This two day meeting is an important milestone in the mHealth industry so stay tuned for regular updates throughout the conference. You can follow the conference as #FDAmhdef