Arunkumar Prabhakaran, Regulatory Affairs Consultant
FDA released a new final guidance document for medical device software documentation on June 14, 2023, replacing the existing guidance document released in 2005. This new guidance document helps determine the software documentation required for premarket medical device submissions (510(k), De Novo, IDE, HDE, BLA). These recommendations also apply to device software functions in combination products, which are reviewed under Drug or Biological product market submissions.
What is in the new guidance?
Per the new guidance, the software documentation level (either Basic or Enhanced) required for premarket submissions will be determined via a risk-based approach. According to the guidance, the determination goes as follows; if a “failure or flaw of your device software functions could present a hazardous situation with a probable risk of death or serious injury, either to a patient, user of the device, or others in the environment of use,” then you should submit software documentation per the Enhanced level. If the Enhanced level does not apply to your device software functions, then a Basic level documentation is sufficient. The following table will give you a high-level idea on the documents required for both the level.
Recommended documentation for each level
Basic Level
- Software description
- System and Software Architecture Design
- Risk management file
- A complete Software Requirements Specification (SRS)
- Software development, configuration management, and maintenance practices (DOC to IEC 62304 or summary of the life cycle development plan)
- Software Testing as part of V&V - summary description of V&V at unit, integration, and system level (including protocol & results for system level testing’s).
- Revision level history
- Unresolved Anomalies
Enhanced Level
All the Documents from the Basic Level, PLUS the following documents:
- Complete SDS document
- Completed configuration management and maintenance plan document(s) or DOC to IEC 62304
- Complete Protocol and results for unit, integration, and system level V&V testing
Guidance changes may lead to some turbulence
The transition required by this new guidance may be particularly burdensome for engineers and software developers. With such a significant shift, figuring out what changed from the previous software guidance to the new guidance can be difficult. And the clock is ticking: 60 days from the publication of the guidance, FDA expects to receive software documents based on the new guidance.
You and your team might have questions about this new guidance. Do I need to prepare additional documentation work? How to decide the documentation level? Is it critical to know about the documentation level during the early stages of software development? Well, RQMIS can determine the appropriate documentation level for your device type and guide you through the software development process.
RQMIS has experience with FDA’s software documentation guidance.
Moving forward, all medical device software developers, regardless of SW risk, must provide most of the software documentation (including a complete SRS, architecture design chart, and risk management file) in the premarket submission as a minimum requirement. Let RQMIS help your team prepare. We’ve already helped our clients address the new requirements. We have experienced Regulatory and Medical Device Software developers ready to help you ensure nothing gets missed when submitting for your medical device software