What is 21 CFR 820?

[@assassinsylvia8117]

0:41 - 1:54 The base definition and explanation of what is 21 CFR 820

[@MedicalDeviceAcademy]

Excellent! Timestamps have been added.

[@joshvazquez9298]

Great video. I can’t Believe no one has commented yet. PS been on KZbin from the beginning and you’re the first person I’ve ever commented. Keep up the good work.

[@MedicalDeviceAcademy]

Thank you very much Josh. I appreciate the comments. Any suggestions for new content is always welcome! Rob

[@jbernajs4337]

Great video!

[@MedicalDeviceAcademy]

Glad you enjoyed it

[@assassinsylvia8117]

I have a question to possibly add to the what is series. What is a design fmea? What is a process fmea?

[@MedicalDeviceAcademy]

Those are good suggestions for our "What is []?" playlist. We already have one video on the FMEA: kzbin.info/www/bejne/maWZgKx5gLd0h80, but a couple of short videos where we display examples would be helpful. I'll also add a few of the other risk analysis tools, such as a FTA.

[@ashutoshpanda1031]

Great video sir,🙏.thank you.

[@MedicalDeviceAcademy]

Most welcome

[@ApurvWankhede]

Would like to know more about the 21 CFR 820 specific to Design control

[@MedicalDeviceAcademy]

We just happen to have a playlist with 19 videos on that topic: kzbin.info/aero/PLUMSoOrFSw9cV2lOn9r_nKA29z5EK0ou3&si=uGJXouNXwCnHc2eV

[@humanfactorsengineering62366]

In their 2016 Usability Guidance the FDA says that Human Factors Engineering represents one portion of design validation. Then the QSR doesn't mention usability at all in 820.30, how would you incorporate that into design controls?

[@MedicalDeviceAcademy]

Although the QSR does not include human factors or usability, the QMSR that goes into effect on February 26, 2026 will incorporate ISO 13485:2016 by reference. In Clause 7.3.3 (i.e., Design Inputs), the IEC 63266-1 standard is referenced. Therefore, companies are expected to establish use specifications and user interface specifications as part of the design process and these specifications would be verified and validated. In other countries, the requirements to include usability are specifically indicated as an essential principle of safety and performance.

[@neelvek-wj6ih]

Very informative

[@MedicalDeviceAcademy]

Glad you think so!

[@MedicalDeviceAcademy]

Glad it was helpful!

[@balajiakkayyagari8454]

very helpful

[@MedicalDeviceAcademy]

Glad it helped. If you have any suggestions for future videos, please let us know.

[@assassinsylvia8117]

Fun Facts with rob - Some History on 21 CFR 820 3:39 - 4:25

[@MedicalDeviceAcademy]

Now that I have added the timestamps, if you are not a history buff you can skip to the next time stamp where I talk about the need to modernize the QSR.