I have just been reading an interesting little aside on Mobihealthnews I thought I would share with you. As more and more developers are make applications (apps) for the Apple iPhone, using at as in interface for medical devices is an obvious solution and one that make allot of commercial sense. However it raises a number of issues that the FDA are currently struggling with. Any medical device needs to be approved by the FDA, and in the context of a medical device app, the iPhone becomes a medical device. However Apple have not sought FDA approval, and I would suspect are unlikely to do so, so are they in violation? its a tough call. Apple have put in a clause in their contract with application developers that the developer seeks all regulatory approvals etc, in their eyes passing the buck to the developers, however its not clear if that is acceptable to the FDA, you can’t usually contract away responsibility for medical compliance, watch this space for more on this interesting topic.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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