FDA is issuing this draft guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.
FDA envisions a future state where the medical device ecosystem is inherently focused on device features and manufacturing practices that promote product quality and patient safety.
FDA has sought to identify and promote successful manufacturing practices and help device manufacturers raise their manufacturing quality level.
In doing so, one goal is to help manufacturers produce high-quality medical devices that align with the laws and regulations implemented by FDA.
Compliance with the Quality System regulation, Part 820, is required for manufacturers of finished medical devices to the extent they engage in operations to which Part 820 applies.
The Quality System regulation includes requirements for medical device manufacturers to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications (21 CFR 820.70, Production and Process Controls), including requirements for manufacturers to validate computer software used as part of production or the quality system for its intended use (see 21 CFR 820.70(i)). Recommending best practices should promote product quality and patient safety, and correlate to higher-quality outcomes.
In recent years, advances in manufacturing technologies, including the adoption of automation, robotics, simulation, and other digital capabilities, have allowed manufacturers to reduce sources of error, optimize resources, and reduce patient risk.
FDA recognizes the potential for these technologies to provide significant benefits for enhancing the quality, availability, and safety of medical devices, and has undertaken several efforts to help foster the adoption and use of such technologies.
When final, this guidance is intended to provide recommendations regarding computer software assurance for computers or automated data processing systems used as part of production or the quality system.
This guidance is not intended to provide a complete description of all software validation principles.
FDA has previously outlined principles for software validation, including managing changes as part of the software lifecycle, in FDA’s Software Validation guidance.
This guidance applies the risk based approach to software validation discussed in the Software Validation guidance to production or quality system software.
This guidance additionally discusses specific risk considerations, acceptable testing methods, and efficient generation of objective evidence for production or quality system software.
The following approach is intended to help manufacturers establish a risk-based framework for computer software assurance throughout the software’s lifecycle.
- Identifying the Intended Use
- Determining the Risk Based Approach
- Determining the Appropriate Assurance Activities
- Establishing the Appropriate Record
