In order to avoid the potential risks of mobile medical applications, the lack of supervision and the existence of damage, the US Food and Drug Administration (Food and Drug Administration; FDA) in September 2013 was also the official announcement mobile medical applications (Mobile Medical Application Final Guidance) guidance In the final version, mobile medical development has also begun to have preliminary compliance standards, which is more conducive to the development of mobile medical. (Whether your app needs to be approved, please check the map: Can your mobile medical APP bypass the FDA)
Like the medical devices regulated by the MDDS (Medical Device Data System), the FDA's principles governing mobile medical applications are also divided into three categories, the division of which is the functionality of mobile medical applications that, if not functioning properly, causes patients The degree of security risk varies.
Michael Righter, director of AliveCor, once said that the FDA essentially requires software supervision. Generally, good software engineers will do these things naturally, such as code review, unit testing, system level testing, change monitoring, etc. These methods usually need to have Experienced developers work closely on software deployments.
FDA Digital Health Product Approval Concise Guide
According to the FDA, there are three types of mobile medical applications that need to be supervised. Class I medical devices are information that can link and control one or more medical devices, or display, store, analyze, and transmit specific medical devices, such as The remote display shows the data monitored by the patient bedside monitor, displays the brain wave map, controls the sphygmomanometer cuff inflation and deflation. Some of these types of applications may require only one 510(k) application, premarket notification before entering the market, and are simpler than other types of apps.
Class II medical devices are functions that can be converted into regulated mobile medical devices by means of accessories, displays, sensors, or medical devices that are currently regulated by regulations, such as attaching mobile devices to blood glucose test strips. The App on the device is then used to check the blood glucose to make the mobile device a blood glucose meter. Almost all such medical devices are required to automatically submit a 510(k) application and make a pre-sales notice.
Class III medical devices are stand-alone software that can perform analysis of specific patients and provide specific patient diagnosis or treatment recommendations for analyzing medical device data. FDA considers it to be an accessory to medical devices. Therefore, the classification it supervises will be the same as the classification of the highest risk equipment in various materials. This type of medical device must be approved by the FDA for premarket approval. During this period, clinical trials are required, and the time required for different products varies, several years or even longer, and the cost is high.
Personalized KinetiGraph, a mobile medical device developed by Global Kinetics, Inc., which monitors and treats Parkinson's disease, provides comprehensive automated reporting of Parkinson's activities, making it easier for neurologists and other physicians to identify motor symptoms. Change to help make decisions to optimize treatment.
What is the difference between the three types of medical equipment? For example, in the case of a bandage, the ordinary bandage is only for covering the wound and has no other effect, and belongs to the class I; it is connected with the mobile phone, and can detect the temperature of the wound through application, and may also be infected with a wound, and there is a slight risk to the consultation, belonging to class II; After connecting the mobile phone, not only the wound related information can be displayed, but also the feedback and guidance of the patient can be given through the drug algorithm, and it is classified into the class III.
Once you have identified your product, then combine the appropriate regulatory path and business model. If your model is a fee, then you may need to publish clinical results and obtain FDA approval.
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