As employers continue to grapple with a safe return to the workplace, on January 21, the U.S. Center for Disease Control and Prevention (CDC) issued new guidance for businesses and employers on SARS-CoV-2 testing of employees, as part of a more comprehensive approach to reducing transmission of the virus in non-healthcare workplaces. While the CDC
FDA Issues Draft Guidance for Connected Medical Devices
Demonstrating a continued focus on information security, the Food and Drug Administration (FDA) published draft guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. As the title indicates, the draft guidance focuses on issues manufacturers should address in the development and design of medical devices prior to sale to consumers.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
FDA Issues Draft Cybersecurity Guidance for Device Manufacturers
Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have
Social Media Guidance Issued For Pharmaceutical Entities
The U.S. Department of Health and Human Services, Food and Drug Administration (FDA) recently issued draft guidance entitled “Guidance for Industry-Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media For Prescription Human and Animal Drugs and Biologics.”
The draft guidance is intended to describe the FDA’s current thinking about how manufacturers, packers, and distributors
FDA Provides Data Security Guidance for Medical Device Manufacturers
Big Data’s impact on medical devices pushes FDA to propose draft guidelines for cybersecurity.
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