mdi Consultants
We would like for our clients to know that FDA has made some updates to the regulatory overview regarding the mobile medical applications recently. We had published an FDA update regarding this development earlier on our website. This update is just a revision of that earlier update
What are these apps?
We all know that mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device. Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance.
Mobile medical apps that the FDA will regulate:
The FDA is taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of “device” and that:
1) are intended to be used as an accessory to a regulated medical device, or
2) transform a mobile platform into a regulated medical device.
Mobile apps span a wide range of health functions. While many mobile apps carry minimal risk, those that can pose a greater risk to patients will require FDA review.
Note:
- FDA’s policy does not require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes.
- FDA’s policy does not regulate the sale or general consumer use of smartphones or tablets. FDA’s policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers.
- FDA’s policy does not apply to mobile apps that function as an electronic health record (EHR) system or personal health record system
IEmail us at [email protected] to know more about 510(k) applications or regulations on the subject and Ref: Mobile Apps.