Is Digital Health Software Subject to FDA Regulation?

By Kristie Prinz | February 18, 2022 | Comments Off on Is Digital Health Software Subject to FDA Regulation?

If you work in the software industry, you may be surprised to discover that digital health software products may be subject to regulation by the Food and Drug Administration (“FDA”).  Some software is considered a software as a medical device (“SaMD”) product or software in a medical device (“SiMD”) product. So, how do you know…

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