SPMC's FAQs provide guidance for your technical challenges.

I've been requested to supply a statement of suitability of LDPE for use in applications involving EtO sterilization. After an extensive search on the Internet it's become obvious that LDPE is suitable and widely used for EtO sterilization, but I have not managed to find any official statement by a regulatory body affirming this. Is there such an affirmation? If so, where can I find it? Thanks in advance.

Last Updated On May 30, 2007

We do not believe that it will be possible to obtain a statement from a regulatory body that will specifically address your request. We assume that your question is directed towards the packaging material for your device, rather then the device itself. If you are requesting this information for a device, the best path to pursue would be to research the 510K archives for a device that is substantially equivalent to the one you intend to market, with the same sterilization process. 510K submissions are public records, and can be searched through the FDA website. The following link is available to search these records:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

You may also try searching the FDA home page for medical devices using key words “ETO sterilization” and “LDPE.” The following is the link to the FDA website:

http://www.fda.gov/cdrh

If your question is related to a packaging material, we believe that the FDA would still require you to perform the necessary testing and qualification work to prove the efficacy of your material in the stated sterilization process. We do not believe that they would accept a statement from a regulatory body, as there are many variations of LDPE, devices, and sterilization methods. Two documents that would be beneficial to you in proving the efficacy of your packaging material or sterile barrier system are ISO 11607, and ISO 10993-7 – available in the following Technical Information Report