Is your media FDA approved?

The ICE Vitrification System is not currently approved by the FDA. However, the FDA does not require clinics to use FDA approved media or devices. They do require that some testing is performed if using a non-FDA approved device/media. This is outlined in Title 21 on their website.

This document states that if using a non-FDA approved media/device one has to have a Certificate of Analysis from the manufacturer. C of A's are availble upon request for all ICE Vitrification media.

Basically, the FDA is concerned for the safety of the patient. They realize that there are other items out there not FDA-approved that work very well and thus will allow you to use them, but they want them to be safe and require similar testing as a FDA-approved item. We do all the same testing, just as if the media were FDA approved. I even do additional testing to make sure the media is good and safe. For instance, a fungal and mold test are performed, this is not required. We also do an actual vitrification and thaw for our Mouse Embryo Assay (MEA) test. This serves as a functional assay, not only an overt toxicity test. We do this to ensure that you are getting the best and safest media.

If your lab is inspected by the FDA, you would show them Title 21 and the CofA's. Same goes with CAP inspection.

We are working on getting FDA approval, but first I want to make sure that there are no other changes to the media or protocol. For example, if I find that a small change in the media or protocol will give better results I will make that change for everyone's benefit. But, if the media were FDA-approved I could not make that change until I got a second approval from the FDA, even thoiugh I know it is better for your patients, they would not allow its use.

Therefore, FDA approval does not necessarily mean that you are using a good product; only that it has gone through some testing. There are numerous FDA approved items, like slow-cooling media, that were approved years ago but do not have very good results, at least compared with some of the more recent freezing products available today, yet the FDA still allows their use!