On February 2015, the FDA has published the new guidance ‘ Mobile Medical Applications’, which supersedes “Mobile Medical Applications: Guidance for Food and Drug Administration Staff” issued on September 25, 2013.
‘The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential benefits and risks to public health represented by these apps. The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.
Many mobile apps are not medical devices (meaning such mobile apps do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act), and FDA does not regulate them. Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act). The majority of mobile apps on the market at this time fit into these two categories.’
FDA is issuing this guidance to provide clarity and predictability for manufacturers of mobile medical apps.
In the guidance, the ‘Mobile Medical Application’ (Mobile Medical App) is defined as a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 4; and either is intended:
- to be used as an accessory to a regulated medical device; or
- to transform a mobile platform into a regulated medical device.
The guidance applies to:
- Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or for use in active patient monitoring or analyzing medical device data.
- Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.
- Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.
‘Manufacturers of mobile medical apps are subject to the requirements described in the applicable device classification regulation below. Depending on the classification and the associated regulation for the mobile medical apps, manufacturers of mobile medical apps are required to follow associated controls established by the regulation.
- Class I devices: General Controls, including:
- Establishment registration, and Medical Device listing (21 CFR Part 807);
- Quality System (QS) regulation (21 CFR Part 820);
- Labeling requirements (21 CFR Part 801);
- Medical Device Reporting (21 CFR Part 803);
- Premarket notification (21 CFR Part 807);
- Reporting Corrections and Removals (21 CFR Part 806); and
- Investigational Device Exemption (IDE) requirements for clinical studies of investigational devices (21 CFR Part 812).
- Class II devices: General Controls (as described for Class I), Special Controls, and (for most Class II devices) Premarket Notification.
- Class III devices: General Controls (as described for Class I), and Premarket Approval (21 CFR Part 814).’
For more accurate information, find attached the link of the guidance: http://www.fda.gov/downloads/MedicalDevices/…/UCM263366.pdf