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.”

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

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