Submissions for devices that are labeled sterile must cite their sterilization method, as well as the method used to validate the sterilization cycle. The notification does not, however, have to include actual validation data. The device’s sterility assurance level (SAL) that the manufacturer intends to meet must be included. Note that an SAL of 106 is a common industry standard, and that the FDA usually will not accept anything below it. When ethylene oxide (EtO) is to be used to sterilize the device, mention must also be made of the maximum levels of residues of EtO, ethylene chlorohydrin, and ethylene glycol on the device. If radiation sterilization is used, the radiation dose must be stated. The submission should also describe the packaging used to maintain device sterility, but need not include data on packaging integrity.
For devices that contact blood or cerebrospinal fluids, the submission should state whether the device is nonpyrogenic, and describe the method used to make that determination. If the entire device is not labeled sterile or nonpyrogenic, the labeling must clearly identify the parts that are nonpyrogenic and sterile. The relevant guidances on sterility should be consulted.126,127 Sterilizers intended for use in health-care facilities must meet the appropriate 510(k) requirements in these documents.
Pyrogens. If the device contacts blood or cerebrospinal fluids and will be labeled nonpyrogenic, state the process controls that will be used to control pyrogens. State also what method, such as the Limulus amoebocyte lysate (LAL) or the USP rabbit test will be used to determine that each lot is nonpyrogenic.
Sterilization by User. The labeling for devices intended to be sterilized by the user must identify at least one validated method of sterilization. The instructions should be detailed and specific enough for the user to follow and obtain the required SAL. The instructions should also adequately describe any precautions to be followed, such as special cleaning methods required, changes in physical characteristics of the device that may result from reprocessing and resterilization (especially those that may affect the device’s safety, effectiveness, or performance), and any limit on the number of times the device can be resterilized and reused without adversely affecting its safety, effectiveness, or performance.