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FDA’s Digital Health Navigator
(Thursday, December 15, 2022) The regulation of medical software by FDA, whether it is used standalone or as a component of another device, is rife with confusion. FDA released an online tool this week that attempts to answer the most common questions from software-as-a-medical device (SaMD) developers. SaMD products come in several forms. These could be simple health related mobile phone apps managing routine health related functions, or software making medical decisions based on artificial intelligence (AI) algorithms or running hardware. Software may be regulated in one of three ways. First, it could be considered similar to a conventional device and require a 510k or PMA approval prior to commercial use. These are software involved in well-defined therapeutic or diagnostic applications, those used to provide primary or sole analysis of diseases or medical indications, and software running medical device hardware. Second, it could be a device that is considered low risk and subject to enforcement discretion by the FDA whereby the device can be marketed legally without formal approval subject to FDA stepping in if there are safety events related to the device. These include software that provide secondary or supportive analysis but require a physician’s intervention for medical decisions called as clinical decision support software, supplementary software for additional functionality for a medical device, and those used to record, store analyze, transmit or converting data to various formats. And third, it may be a software that does not meet the criteria of being defined as a medical device. These include wellness software that tracks routine medical information about one’s health not directly linked to a disease or indication, tracking or calendar software, administrative support software, and medical records software. These regulatory policies have been published in various guidance documents and other publications by the FDA over the last decade. The Digital Health Policy Navigator pulls all the software related information in one place and offers a Q&A format where by answering a few simple questions about the software’s design and intended use, developers can get suggestions for the applicable regulatory pathway for their software. The major limitation of the tool is that while it points towards potential answers to common questions, there is no formal output or report that one can share with others as a formal FDA advise. The tool is based on answering up to seven questions about a given software but does not require a user to go through all. It would have been ideal if the tool made the user go through all the potential questions about their software and then provided a score for most applicable regulatory pathway. That would give the users more confidence in the information provided. Lacking this, the tool seems superficial. Perhaps FDA was worried about users drawing hard conclusions based on the online tool and wanted it to be used only for screening and not for definitive regulatory opinion. While the tool answers common questions otherwise harder to find on FDA’s website, it would have limited use for experienced developers. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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