FDA Provides Additional Guidance for Digital Health Products
​​​[Posted on: Thursday, May 10, 2018]

In continuation of its efforts to simplify and limit regulation of digital health products, specifically software application that can be used for health-related outcomes, FDA released two new documents this week. Its guidance document on multiple-function devices, namely devices that are used both for regulated and non-regulated functions; FDA describes how it intends to only require documentary evidence for the regulated functions while not evaluating the whole device. A given device could have core functionalities that are used for other things, for example, the camera of a smart phone can be used to take all kinds of pictures, but some pictures, say of lesions on the skin, can be used to diagnose cancer. So, FDA would only require documentation for the algorithm used to analyze the image for incidence of cancer but not the camera or the rest of the smartphone device. This is a logical approach in line with the previously announced efforts to limit unnecessary regulatory burden. The other document summarizes FDA’s Software Pre-Certification Program. In this document, FDA describes how it has developed its pre-certification program with the initial industry partners. The pre-cert program starts with establishing the excellence of the pre-certified organizations, followed by identification of the appropriate review pathways for the software products developed by the pre-certified companies. Then the software products are subject to risk-based streamlined review, ending with collection of real world evidence data to evaluate performance. Again the approach seems logical and justified. Both these documents should provide tips to health-related software developers and lead to easier discussions with the FDA reviewers, whether or not they are pre-certified.