Effective March 21, 2016, FDA released updates to the guidance Submission and Review of Sterility Information in Premarket Notification (501(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff. Specifically, the document addresses an update to new medical devices and pyrogenicity testing. Although the guidance does not set new regulatory standards, it does represent FDA’s current and future considerations on Bacterial Endotoxin Testing (BET) for “implants; devices in contact directly or indirectly with the cardiovascular system, the lymphatic system, or cerebrospinal fluid, including devices that are present for similar systemic exposure; or devices labeled non-pyrogenic.”
Currently, this notification is just for new 510(k) medical devices. For new medical devices that fall under this guidance, Nelson Laboratories recommends including a statement to FDA that the manufacturer is going to perform BET on every lot or batch to demonstrate that the product meets the appropriate endotoxin limit based on the patient contact in support of a non-pyrogenic label claim.
However, manufacturers of products that are already on the market, or are currently going through approval, should start evaluating the need for BET if lot release testing is not currently performed. For medical devices that fall under this guidance and are currently market-ready, Nelson Laboratories recommends looking at the product and manufacturing process today to determine if the requirements for lot release testing in USP<161> are being met or if a reduced sampling plan is in place that it is compliant with the condition outlined in ANSI/AAMI ST72:2011.
Nelson Laboratories can assist sponsors in preparing their compliance statement upon request when performing validation tests. Please refer to the guidance document with questions or contact Nelson Laboratories at [email protected].