Demonstrating a continued focus on information security, the Food and Drug Administration (FDA) published draft guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. As the title indicates, the draft guidance focuses on issues manufacturers should address in the development and design of medical devices prior to sale to consumers. This
draft guidance
FDA Issues Draft Cybersecurity Guidance for Device Manufacturers
By Jason C. Gavejian on
Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have…