FDA regulation
FDA Releases Final Guidance on Cybersecurity for Medical Devices
The Food and Drug Administration (“FDA”) has issued final guidance to advice developers on their compliance obligations for premarket submissions. To view the FDA’s finalized document, please click here: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (fda.gov). The guidance issued by the FDA supersedes the earlier draft guidance issued on…
Read MoreIs 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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