E
esalsan
Dear covers,
I work for a medical device manufacturer that sells products in Europe and the USA. For this post I am particularly interested in the FDA regulations.
I have read 21 CFR 801 (labeling requirements) and the FDA labeling guidance (published in 1997) and I have understood the difference between label and labeling. It also is very clear to me, what are the label requirements, but I don't understand what the labeling requirements are.
For instance, I always thought the intended use, contraindications, warnings and precautions should be displayed in the labeling, i.e., including product brochures and website content. However, I have been checking our competitors' websites and promotional materials (particularly their product brochures) and none of them include the intended use of the device nor any of the other mentioned items.
Any ideas? Where could I check what information is required to be in the labeling?
Thank you.
Eva
I work for a medical device manufacturer that sells products in Europe and the USA. For this post I am particularly interested in the FDA regulations.
I have read 21 CFR 801 (labeling requirements) and the FDA labeling guidance (published in 1997) and I have understood the difference between label and labeling. It also is very clear to me, what are the label requirements, but I don't understand what the labeling requirements are.
For instance, I always thought the intended use, contraindications, warnings and precautions should be displayed in the labeling, i.e., including product brochures and website content. However, I have been checking our competitors' websites and promotional materials (particularly their product brochures) and none of them include the intended use of the device nor any of the other mentioned items.
Any ideas? Where could I check what information is required to be in the labeling?
Thank you.
Eva