In January of 2016, FDA released the guidance document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. Although the title of this document indicates that it is for sterility testing, much of the information is dedicated to endotoxin testing.
Specifically, this document established new expectations for implants, in addition to devices, that are labeled as non-pyrogenic, or that directly or indirectly contact the cardiovascular system, the lymphatic system, or cerebrospinal fluid. Because of this new guidance document, implant manufacturers whose 510(k)-approved devices contact these areas may need to prepare to update their 510(k) clearance.
Historically, implants were exempt from USP <161> Transfusion and Infusion Assemblies and Similar Medical Devices, so endotoxin testing was not previously required. FDA now expects the following information to be included in the submission: a description of the method used, the endotoxin limit, an explanation supporting the limit, and a statement confirming that endotoxin testing will be done on every batch or a sampling plan. This webinar will include a review of the regulatory expectations for endotoxin testing, endotoxin limits, test methods, and example sampling plans. The information presented will be beneficial for medical device manufactures and QC professionals.
This webinar will include:
- Regulatory expectations for endotoxin testing
- Endotoxin limits
- Test methods
- Sampling plans