Every article in our archive in FDA.
Showing 12 of 46 articles in FDA · Page 1 of 4
FDA clearance is the beginning of your cybersecurity obligations, not the finish line. Postmarket cybersecurity for medical devices is an active, continuous requirement that most manufacturers underestimate until a problem forces their hand. Most invest significant resources building premarket docum
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Receiving an FDA cybersecurity Additional Information Request (AIR) doesn't mean your submission is dead. It means the clock is ticking, and the next move has to be precise. FDA issues these requests when reviewers find specific, documented gaps in your cybersecurity package, and they expect every g
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Here's a pattern Blue Goat Cyber sees regularly: a medical device manufacturer arrives at premarket submission with an ISO 27001 certificate in hand, convinced their cybersecurity story is complete. Weeks later, a deficiency letter arrives. The FDA isn't questioning their information security postur
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Understanding what causes the FDA to issue a cybersecurity deficiency for medical devices starts with one uncomfortable truth: most deficiencies have nothing to do with a bad device. The device might be perfectly secure. The submission just didn't prove it. FDA reviewers work from documentation, not
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Most 510(k) deficiencies don't fail on clinical data. They fail on cybersecurity. FDA reviewers are sending Additional Information (AI) requests, and outright Refuse-to-Accept (RTA) holds, at a rate that has become the primary timeline risk for connected device submissions. The documentation bar has
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Device teams consistently make the same mistake with SPDF (Secure Product Development Framework) cybersecurity documentation: they treat it as a paperwork exercise and assemble artifacts at the end of development instead of generating them as engineering work happens. The result is a submission that
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Performing a thorough cybersecurity risk analysis for a medical device isn't optional once your product qualifies under Section 524B of the FD&C Act. The FDA's 2026 cybersecurity guidance is direct: if your device meets the "cyber device" threshold, you must demonstrate reasonable assurance of cyber
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Every premarket submission for a cyber device now legally requires a software bill of materials, and missing it can get your submission refused outright. Building a compliant medical device SBOM isn't optional under Section 524B of the FD&C Act, enforced since October 2023. This isn't a recommendati
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Getting a 510k deficiency letter for cybersecurity is not a rejection. It is a specific, addressable request from the FDA that tells you exactly what documentation is missing or insufficient. At Blue Goat Cyber, we have guided device manufacturers through this situation repeatedly, and the pattern i
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The FDA's February 2026 cybersecurity final guidance made one thing unmistakably clear: penetration testing is no longer something manufacturers can bolt on at the end of development. For cyber devices under Section 524B of the FD&C Act, it is a required, documented, and reviewable part of premarket submissio
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The FDA's cybersecurity guidance for medical devices is no longer a best-practices document. Since March 29, 2023, it is an enforceable submission criterion. Fail to meet it, and your 510(k), PMA, or De Novo can be denied outright. That's not a hypothetical. It's the regulatory baseline device teams
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The Food and Drug Administration (FDA) has prioritized medical device cybersecurity in recent years. They issued updated guidance most recently on February 3, 2026. With cyberattacks increasing and products becoming more complex, they’re a target for hackers. The healthcare industry has long been
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