Static Analysis: One Piece of the FDA Compliance Puzzle
The FDA recently drew attention to static analysis as it publicly recommended that developers of software for infusion pumps use static analysis as part of their overall process for ensuring medical device software safety and reliability. Furthermore, in numerous speaking sessions, the FDA has been touting the technology's capability to automatically prevent software defects—further indicating that it regards static analysis as a critical component of an effective software development process.
When considering this current spotlight on static analysis for medical device software, it is critical to remember that the FDA’s General Principles of Software Validation recommends a comprehensive software development lifecycle (SDLC) that integrates risk management strategies with principles for software validation:
This guidance recommends an integration of software life cycle management and risk management activities. Based on the intended use and the safety risk associated with the software to be developed, the software developer should determine the specific approach, the combination of techniques to be used, and the level of effort to be applied. While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throughout the entire software life cycle.
Such a process could very well include static analysis—which, when deployed as part of a continuous quality process, has proven to be a very efficient way for developers to expose and prevent many critical defects as the code is being written.
However, it's important to remember that in addition to static analysis, the FDA guidance highlights many complementary practices for ensuring software safety and reliability. The high-level recommendations encourage organizations to adopt an integrated set of quality practices that provide the recommended "mixture of methods and techniques to prevent software errors and to detect software errors that do occur"—for instance, static code analysis, code reviews, unit testing, manual testing, and test coverage analysis.
Moreover, it's also important to recognize that even with the ideal mixture of testing techniques, quality software cannot be delivered by testing alone. Quality software is delivered consistently via a solid, repeatable process. Such a process requires an integrated system that assists with defining requirements, ensuring good coding practices, and testing effectively. It needs to embrace everything from software test and analysis, to quality planning, to requirements traceability, to change management. This process needs to be visible, measurable, and—most importantly—improvable.
To assist organizations that are exploring static analysis for FDA compliance, our next series of posts will look at static analysis in the context of FDA compliance. Moreover, since static analysis is not a silver bullet for FDA compliance, it also explores ways that teams can establish a comprehensive process for producing medical device software consistently and efficiently, with freedom from unacceptable risks.
Image credit: Mykl Roventine
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