Several mobile medical applications are being developed by various manufacturers. These applications are useful to manage patients better. So far, the Food and Drug Administration (FDA) has not issued any guidelines for the manufacturers of these products. In the present article, the FDA has requested interested individuals to send comments regarding the policies that can be included in framing these guidelines.
A “mobile medical app” is a mobile software that meets the definition of “device” as given by the Federal Food, Drug, and Cosmetic Act (FD&C Act). To meet this requirement, the medical app should be either used as an accessory to another regulated medical device, or should “transform a mobile platform into a regulated medical device.” As they are very often used in the management of critically ill patients, their quality needs to be monitored, especially by organizations such as the FDA. However, the FDA has not yet issued any guidance for manufacturers or distributors who develop these mobile applications. The FDA is now in the process of drafting these guidelines. Before issuing these guidelines, the FDA wishes to gather suggestions from the public as well as manufacturers, so that appropriate and meaningful guidelines can be included in the draft. After a thorough evaluation of mobile medical apps, the FDA intends to enforce its authority to maintain the quality of mobile medical applications.
The FDA has requested suggestions and recommendations regarding the ways of examining mobile medical applications to check their effectiveness and safety. Moreover, it wants comments regarding their classification. For example, at present, an infusion pump stand is a Class I medical device while an infusion pump is a Class II medical device. Hence, a mobile medical application, which only serves as an accessory to a medical device could be classified as a Class I device. The FDA also intends to monitor the software used in mobile medical applications and has requested comments on this aspect as well. Comments need to reach the FDA by October 19.
* The draft containing the guidelines for manufacturing mobile medical applications is being prepared according to FDA’s Good Guidance Practices regulation.
* This draft represents the FDA’s present opinion about good quality medical mobile applications.
* The final guidelines issued by the FDA must be implemented by all manufacturers, so that the quality of mobile medical applications can be maintained. These will be made available online on FDA’s Web site.
In the present article, the FDA has requested recommendations from the general public as well as manufacturers for framing guidelines for the manufacturers of mobile medical applications. Mobile applications have broad applicability and their use is rapidly increasing. Suggestions and comments received by the FDA will help it in clarifying the types of applications on which it can apply its authority. Comments may be sent by e-mail or fax. The draft that is prepared will be made available on FDA’s website. However, it should be noted that this draft by itself is not final and it will not be put into force immediately.
For More Information:
Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications and Availability
Publication Journal: Federal Register, July 18, 2011
By Nancy K. Stade; Center for Devices and Radiological Health, Silver Spring, Maryland