With the goal of robust security controls amid emerging and potentially hazardous threats, the US Food and Drug Administration (FDA) has updated final guidance for demonstrating cybersecurity of ...

The US Food and Drug Administration (FDA) has published a premarket cybersecurity guidance almost a decade in the making. The document adds requirements based on new authorities granted to the agency ...

Since 2023, the medical device industry has been on a path to increased cybersecurity. The Food & Drug Administration issued guidance that year, creating new recommendations for premarket submissions.

Blue Goat Cyber leads medical device cybersecurity compliance, helping manufacturers meet the FDA’s finalized cybersecurity guidance issued June 27, 2025. We help medical device manufacturers not just ...

In 2022, Section 524B was added to the Federal Food, Drug and Cosmetic Act through a spending bill, granting FDA new authority over medical device cybersecurity regulation. Now that Section 524B is ...

The U.S. FDA released the latest version of its premarket cybersecurity guidance regarding medical devices, replacing the 2025 edition and offering recommendations on implementing measures for ...

In April of this year, the FDA released a five-point action plan to improve medical device safety that included a clear focus to reduce cybersecurity existing vulnerabilities and promote strong ...

In August, the Food and Drug Administration published a guidance recommending hospitals move away from using Hospira’s Symbiq Infusion System, a computerized pump designed for continuous infusion ...

The Food and Drug Administration should increase its scrutiny of the cybersecurity of networked medical devices before they're approved to be marketed, a new government watchdog agency report says.

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity ...