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.
Grow your Expertise for Free
As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.
For Assistance with Regulatory Planning and Exicution of Clinical Trials Click Here
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my 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.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!
Fill Out the Short Form Below… |
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
