US

RegulationsStandardsOther relevant documents

• The Food, Drug, and Cosmetic Act (FD&C Act)
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)

• ISO 13485:2016 Medical devices --- Quality management systems --- Requirements for regulatory purposes
• ISO 14971
• ISO/IEC 27001:2022 Information security, cybersecurity abd orivacy protection - Information Security Management Systems - Requirements
• ISO/IEC 27701:2019 Security techniques

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff
• Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Guidance for Industry
• Device Advice: Comprehensive Regulatory Assistance