The US Food and Drug Administration’s (FDA) Digital Health Software Precertification (Pre-Cert) Program represents a feasible approach for regulating software classified as a medical device, particularly for software involved in diagnostics and disease treatment, according to a paper published in Medicine in Public Issues. However, despite its practical applicability, Pre-Cert presents some limitations, such as its lack of incentives for formal product research.

The focus of the Pre-Cert Program will be primarily on freestanding software, such as mobile applications designed to manage depression or diabetes, while providing developers with quality control processes to improve app efficiency. Overall, the program is aimed at helping new and innovative medical software arrive on the market quickly while ensuring effective utility for patients.

Despite this involvement, the program does not provide incentives for developers to study their product in a clinical trial environment. Although medical software device companies may excel in best practices for testing software internally, the company may avoid clinical trials to understand the software’s safety and effectiveness in the real-world setting because of the lack of incentives. Ultimately, this deficiency of the program makes further FDA involvement imperative to reduce the likelihood of future recalls.

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Postmarket surveillance is offered with the Pre-Cert Program, which may “mitigate the risk of inadequate preapproval data collection,” according to the authors. In addition to monitoring efficacy and safety, the program will also need to determine whether the confusion of a software’s functionality among patients and physicians outweigh its proposed benefits. These standards may help facilitate improved device development in the future, ultimately advancing technology’s place in healthcare.

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Proper safety and effectiveness research is required during some point in the software lifecycle, as without the appropriate data, the Pre-Cert Program “will ascribe FDA validation to more new products that have not established actual clinical benefits.”


Lee TT, Kesselheim AS. U.S. Food and Drug Administration Precertification pilot program for digital health software: weighing the benefits and risks. Medicine and Public Issues [published online April 9, 2018]. Ann Intern Med. doi:10.7326/M17-2715