FDA (US Food and Drug Administration) Labeling Requirements

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

According to FDA @
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/default.htm
They describe the label and labeling requirements very generally.
The documentation you speak of sounds like it is a bit short of correct.
Advertising has developed into a story of needing a product, and then in endless wording the harmful side effects and that a doctor should be consulted.
Section 201/206 of the Federal Food, Drug and Cosmetic Act (FFDCA) is the reference for the FDA inforcements of "labeling".
There are many, and varied exemptions and variances. So there can be no sweeping they are wrong statement.
Happy hunting.

If someone with "hands on" experience can help it will be appreciated. My Thanks in advance.

esalsan said:

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?

Click to expand...

Generally the FDA's stance is that incorrect actions by company X do not establish a precedent for acceptability of identical behavior by company Y.

The best guidance is the published Guidance, plus of course the 21CFR rules.

You may know of the FDA's DSMICA inquiry line. If you don't, you can learn more by searching on that term at the CDRH website. As far as I know, overseas companies can use this as well, as long as they are "small businesses". You can discuss labeling expectations for your particular product with them.

Thank you all, although I didn't write exactly what I meant to. I am familiar with the FDA regulation and guidance documents and our labels contains all the required information.

However, product literature, including brochures, posters, etc., and website content are also considered labeling. I am looking for specific requirements for those (other than being truthful and in accordance with the device intended use) as I suspect I have been too careful and ours contain much more information that they are required to (which is not necessarily wrong, just wondering...).

Thank you again for your (already useful) information.

Miregmgr, I don't think do qualify as small business but I'll check about the DSMICA inquiry line.

Dear All, There is something unclear for me, because it seems that the FDA is requiring to have exact wording for the indications for use written on the instructions for use, packaging and 510(k) file but should be absolutely 100% identical ? The problem is that sometimes you can use one IFU for several products and also 510(k) and what can be done on this case, should we list each indication for use statement for each product ? This takes a lot of space, can we use a symbol like this "*Products x" and refer to the different products names in smaller *x = blabla ? Many thanks

I don't understand what question is being asked.

Usually when multiple products use the same IFU insert sheet, for instance, those products are closely related and in fact have the same instructions for use.

It should be workable to use product lists to indicate which items are subject to IFU statement A, and which items are subject to statement B, etc., as long as the meaning is clear to the end user.

Sorry for not being enough clear. My question is do we need to have the exact sentence written in the IFU/packaging and in the Indications for use statement of the 510(k), meaning that only the product name will be different as given in details in the indications for use statement but given under general name in the IFU. For example, in the indications for use statement in the 510(k), we have "Implant X is designed to replace a tooth" where in the IFU we have "Dental implants are used to replace tooths".