FREQUENTLY Asked Questions

When is a software development environment description required?

View All FAQs
About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

For Moderate and Major Level of Concern Software Devices, the submission should include a summary of the software development life cycle plan. This summary should describe the sponsor’s software development life cycle and the processes that are in place to manage the various life cycle activities. For Major Level of Concern Software Devices, this document should also include an annotated list of the control/baseline documents generated during the software development process and a list or description of software coding standards.

As mentioned elsewhere, configuration or change management is a crucial aspect of software development. Changes to the Software Device after initial market release should be subject to positive control, with definitive specification and test plans including well-defined regression testing where appropriate. The description of the development environment should provide information on your configuration management and maintenance plan that addresses these aspects of the software development life cycle. For a Major Level of Concern device, FDA recommends that you provide sufficient detail to allow for a thorough understanding of the configuration management and maintenance plan. For a Moderate Level of Concern device, FDA recommends that you provide only a summary of the configuration management and maintenance plans.

Related Terms:
No items found.
Related FAQs:
More Questions? We're here to help!
SPEAK WITH A SPECIALIST