This short Q&A article discusses the role and impact of FDA regulation, as well as the new medical device excise tax.

Some thoughts…

• Someone explain to me how applications accessed on a tablet or smartphone are so much different than a desktop app being accessed on a netbook on Wifi. A tablet is a computer, typically without a keyboard and mouse. The user input method varies slightly and we have a whole new class of device? I don’t get it. If an application is collecting clinical data (e.g. dermatology photo), it should be subjected to appropriate regulations regardless if the user is using a mobile computer or a full desktop to run the application. This seems to me like a lack of understanding of computing by policy makers.
• I believe the driving issue are mobile app developers getting into healthcare rather than registered medical device manufacturers getting into building mobile apps. Those familiar FDA regulations (and similar ones in other jurisdictions) generally know the rules. It is the mobile app developers unaware of the FDA regulations that are likely facing the greater challenge (mostly learning the requirements of being a medical device manufacturer). Providing the right guidance to the app developer community could be a growing opportunity for experienced regulatory affairs contractors/consultants.