FDA Explains What Mobile Apps Are No Longer Devices

Regulatory NewsRegulatory News | 26 September 2019 |  By 

A section of the 21st Century Cures Act (Cures Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and removed certain software functions from the definition of a medical device. In addition to drafting new guidance on clinical decision support software, the US Food and Drug Administration (FDA) on Thursday released final guidance explaining what digital health products are no longer devices and are no longer subject to FDA regulations.

Examples of such mobile apps that are no longer considered devices include those that calculate calories, those intended for individuals to log, record, track, evaluate or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness, and those that monitor food consumption, among others.

In addition, FDA says Laboratory Information Systems (LIS) and Laboratory Information Management Systems (LIMS) functions intended for administrative support of laboratories and/or for transferring, storing, converting formats, or displaying clinical laboratory test data and results are not considered to be devices

The agency also notes how certain software functions that are intended to transfer, store, convert formats or display electronic patient records that are the equivalent to a paper medical chart are not considered devices.

To further align these new interpretations and policies under the Cures Act, FDA updated four final guidance documents: Final Guidance on Policy for Device Software Functions and Mobile Medical ApplicationsFinal Guidance on General Wellness: Policy for Low Risk DevicesFinal Guidance on Off-The-Shelf Software Use in Medical DevicesFinal Guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.

FDA also withdrew the following guidance: Guidance for the Submission of Premarket Notifications for Medical Image Management Devices.

Clinical Decision Support Software

Building off IMDRF efforts, which are leveraged in the FDA document, the agency released its 27-page revised draft from 2017 clarifying categories of clinical decision support (CDS) software that would be subject to FDA oversight, low-risk categories of CDS for which FDA does not intend to enforce regulatory requirements and CDS categories that do not meet the definition of a device.

“An example of a product we would focus our oversight on would be CDS that identifies hospitalized, type 1 diabetic patients at increased risk of postoperative cardiovascular events and which does not explain why the software made that identification to the health care professional,” FDA said.

The guidance also interprets the criteria for Section 520(o)(1)(E) of the FD&C Act and offers a series of other examples.

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
Clinical Decision Support Software


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