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USFDA Medical Devices Guidance: Computer Software Assurance for Production, Quality Management System Software & Cybersecurity, QMS Considerations and Content of Premarket Submissions
In February 2026, FDA issued an updated guidance titled Computer Software Assurance for Production and Quality Management System Software , superseding the September 2025 version. In parallel, FDA released an updated Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions guidance, reflecting the growing cyber risk associated with digital and connected medical technologies. Together, these guidances signal a shift awa
Sharan Murugan
2 days ago3 min read
USFDA Draft Guidance: Quality Management Systems and Menstrual Product Standards
The U.S. Food and Drug Administration (FDA) has recently released two significant draft guidance documents that mark important steps forward in the modernization and harmonization of medical device regulations: Quality Management System (QMS) Information for Certain Premarket Submission Reviews Menstrual Products – Performance Testing and Labeling Recommendations Both are designed to increase transparency, strengthen product safety and quality, and align FDA’s approach with
Sharan Murugan
Nov 1, 20253 min read