How review medical device labeling

In this live-streaming video, we demonstrate (live and without preparation) the review of medical device labels for compliance with US FDA requirements.
US FDA requirements for labeling are found at:
➤ www.ecfr.gov/c...
If you need help doing your own labeling review, quality system consulting, or a regulatory submission, please schedule a call with Lindsey Walker to get a consulting proposal:
➤ calendly.com/s...

[@Stwin18]

You are super knowledgeable... are you able to create a video regarding medical device labeling when it comes to Country of Origin and "Made in XXX"? I think they are different but am confused. Is this required on the label or not? Then there is this component of the FTC about "Made in the USA" claims. I am confused. If you have more information, that would be super helpful.

[@MedicalDeviceAcademy]

The country of origin requirements for labeling are outside of the scope of US FDA regulations, and they are different in every country. Therefore, this is not something I can provide a video on. However, there are other videos on KZbin about country of origin. In general, in the USA the expectation is that "Made in the USA" means that the origin of the raw materials and the labor is the USA, while other countries use the more literal terminology to specify the origin of the labor only.

[@anahanah-m7b]

Thanks for your videos, I am learning a lot!

[@MedicalDeviceAcademy]

You are welcome! Any suggestions for the next live-streaming?

[@anahanah-m7b]

Uh, there are some topics, I don't know if you have already spoken about it: Quality Management: SPC . Also: Dealing with non-confom materials, or CAPAs. Sterilized devices.... 😅

[@munasofi5037]

Thanks a lot. Would you please do another video for the CE labeling requirement using an example like this one

[@MedicalDeviceAcademy]

I will consider your request. It might be a few months, but I'm sure one of our CE Marking clients will give me spark of an idea for this.

[@davidboichyn3596]

Great channel and tons of info! My question is, Our company manufactures plastic parts that are components of medical devices (We do not manufacture the actual complete device). Would our company fall under/be required to have software validation for the software used to produce these components? We have been doing software validation for a while now, but im wondering if we even need to do it all together? (I also sent an email)

[@MedicalDeviceAcademy]

The FDA requires that automated processes be validated in accordance with 21 CFR 820.75. This would include the software that runs the equipment. This type of software is different from software in a medical device (SiMD) or software as a medical device (SaMD). For those two types of devices, software validation is explained in IEC 62304-1 and IEC/TR 80002-1. For software used in the quality system, the applicable standard is IEC/TR 80002-2.

[@StevenAnnunziata]

hey, can you hop on a call to go through a review?

[@MedicalDeviceAcademy]

If companies need help with a labeling review, they only need to schedule a call with me: calendly.com/13485cert/30min