Current Status of Computer Software Assurance (CSA) Guidance

Overview

The Computer Software Assurance (CSA) guidance is positioned as a high-priority initiative within the FDA’s Center for Devices and Radiological Health (CDRH). As of the fiscal year 2022 guidance development agenda, CSA guidance was listed at the top of the priority topics, reflecting FDA’s long-standing commitment to addressing software validation requirements for non-product software used in medical device manufacturing and quality systems.

However, as of January 2025, the draft guidance has not yet been issued, despite being designated as a top priority since 2018. This delay reflects the complexity of developing comprehensive guidance that balances industry needs with regulatory requirements.

What is Computer Software Assurance (CSA) Guidance?

The FDA CDRH is developing a draft guidance document titled “Computer Software Assurance for Manufacturing, Operations and Quality Systems Software” (CSA Guidance). This guidance aims to streamline the process of software validation for medical device manufacturers, reducing the documentation burden associated with Computerized System Validation (CSV) while maintaining appropriate quality and compliance standards.

The Challenge of Software Validation

ISO 13485, the international standard for quality management systems in medical device manufacturing, requires validation of software used in several critical contexts:

• Software used in quality management systems (section 4.1.6)
• Software used in manufacturing processes (section 7.5.6)
• Software used for inspection and testing (section 7.6)

These software applications support medical device manufacturing and quality operations but are not themselves medical devices—a category known as “non-product software.”

The CSV Burden Problem

Currently, manufacturers face substantial documentation requirements for Computerized System Validation (CSV) of non-product software. This typically involves extensive time, labor, and financial investment to demonstrate software fitness for intended use, validation of computerized systems, and data integrity compliance.

The proliferation of software in manufacturing environments—from Manufacturing Execution Systems (MES) and Quality Management Systems (QMS) to laboratory information systems (LIMS)—has made CSV a significant operational and financial burden. Manufacturers must validate software to demonstrate that systems operate reliably and produce valid results, but the current regulatory framework lacks specific guidance on proportionate validation approaches.

FDA’s CSA Initiative

Recognizing this regulatory gap, the FDA CDRH has prioritized development of CSA guidance since 2018. The intended purpose of this guidance is to:

• Clarify FDA’s expectations for software validation in manufacturing and quality contexts
• Provide a risk-based framework for determining appropriate levels of validation effort
• Reduce unnecessary documentation while maintaining regulatory compliance and data integrity
• Align with international standards harmonization initiatives

Current Status and Future Outlook

The CSA guidance appeared on the FDA’s FY2022 priority guidance topics list. The fact that it remains a designated priority indicates FDA’s continued commitment to issuing this guidance, although the extended development timeline suggests ongoing internal discussion about scope and approach.

As of January 2025, manufacturers should monitor FDA’s guidance development activities through the following channels:

• FDA CDRH published guidance documents and priority lists
• FDA Guidance Development Council announcements
• Industry roundtable discussions and comment periods when draft guidance is released

Related Development: Cybersecurity in Medical Devices Guidance

In parallel with CSA guidance development, the FDA is also advancing guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” This guidance addresses the integration of cybersecurity controls within quality management systems and their documentation in regulatory submissions.

The International Medical Device Regulators Forum (IMDRF) has similarly been developing cybersecurity guidance, with public comment periods to gather stakeholder input. The convergence of cybersecurity and software assurance guidance suggests a comprehensive regulatory approach to software risk management in medical device manufacturing.

Implications for Device Manufacturers

Manufacturers should prepare for potential changes to their CSV and software validation programs by:

1. Reviewing current software validation documentation practices and identifying opportunities for process efficiency
2. Assessing the criticality and risk profile of non-product software in their operations
3. Maintaining awareness of draft guidance releases and participating in public comment periods when appropriate
4. Considering alignment with international standards (ISO 13485, IEC 62304, and emerging cybersecurity standards)
5. Developing risk-based validation strategies that scale with software complexity and regulatory significance

Regulatory Timeline and Expectations

The extended timeline for CSA guidance development (prioritized since 2018 with no draft released as of January 2025) reflects the complexity of developing guidance that addresses diverse software applications and manufacturer capabilities. The FDA’s regulatory approach to software assurance is evolving in response to:

• Increasing digital transformation in manufacturing
• Advanced manufacturing technologies and Industry 4.0 applications
• Integration of artificial intelligence and machine learning in quality systems
• Harmonization with international regulatory frameworks

Manufacturers are encouraged to track developments in FDA guidance issuances and maintain flexibility in their quality systems to accommodate future regulatory clarifications.