FDA Guidance Home Use Design Considerations.

FDA issued the final guidance “Design Considerations for Devices Intended for Home Use” dated August 5, 2014. The full guidance is at the link provided. Section VII Design Consideration addresses software by stating the following and then referencing IEC 62304 and FDA’s general software guidances: “Software plays a critical role in the operation of some devices. For these devices, you should focus on developing device and software architecture and algorithms for performance, error detection, control, and recovery. When developing a home use device, you should broaden your existing concept development and preliminary testing processes to account for the needs of home users and requirements for straightforward device operation, obvious interface layouts, and appropriate alarm methods. If software upgrades are required, you should consider how this will be performed in the home environment with the lowest risk to the user and least burden on you.”

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.