What are the steps required to create a medical device that can be paired with a medical app on an iPhone or iPad? Technology review tackles this scenario in a recent article, publishing a rough outline of the various items that are required for this to work. They compiled this list by interviewing various developers […]
Tag: FDA medical apps
Accessorizing isn’t just a fashion issue – mobile apps that work with medical devices present a distinct challenge
This session discussed the fragmentation of the healhcare industry and the challenges that arise from classifying an app as an accessory for FDA regulation.
Should your medical apps be regulated in the same way as a defibrillator?
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.
Future scope of regulation debated at FDA mobile medical apps workshop
This post is part of iMedicalApps coverage of the FDA meeting regarding its draft guidance of mobile medical apps.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
FDA regulation of mHealth, part 2: FDA scope & culture
In this article, we are going to delve a bit into FDA culture, the recent final ruling on “MDDS” devices and try to guess how the FDA will interact with future mHealth devices.