FDA Issues Final Guidance For 510(k) Devices Labeled As Sterile

By Jof Enriquez,
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The U.S. Food and Drug Administration (FDA) has released final guidance for manufacturers to include in premarket 510(k) submissions for devices labeled as sterile. The document also includes recommendations on pyrogenicity information for these devices.

In a notice published in the Federal Register, FDA explains that it has received in recent years an increasing number of 510(k)s for devices labeled as sterile that use sterilization methods other than "established" methods of sterilization (i.e., steam, dry heat, ethylene oxide (EO), and radiation). These "novel" sterilization technologies may not comply with Good Manufacturing Practice (GMP) and may pose a risk for infection, and the FDA deemed it fit to issue updated recommendations to include these newer methods.

In addition, FDA proposes to conduct inspections on manufacturing facilities "before clearing a 510(k) for a device that is sterilized by a novel sterilization process" to "help ensure the safety and effectiveness of these devices and mitigate the risks to human health."

The final guidance defines a Novel Sterilization Method as one that "FDA has not reviewed and determined to be adequate to effectively sterilize the device for its intended use." This includes the use of sterilants, used individually or in combination,  which have not been cleared by FDA or have not been identified in scientific literature as sterilants. Examples of novel sterilization methods listed are: vaporized peracetic acid, high-intensity light or pulse light, microwave radiation, sound waves, and ultraviolet light.

Briefly, for established sterilization methods, FDA recommends that sponsors include information such as the description of the sterilization method, sterilization site, sterility assurance level (SAL), pyrogen limit specifications, endotoxin limit information, and a description of the packaging (sterile barrier system). Sponsors also are asked to include how they will maintain the device’s sterility and a description of the package test methods, but not package test data.

For novel sterilization methods, in addition to aforementioned recommendations for established methods, the sponsor should provide the following information:

1. A comprehensive description of the sterilization process;
2. The method used to validate the sterilization cycle (e.g., the half-cycle method);
3. The validation protocol; and
4. The sterilization validation data.

The 510(k) submission should also identify any applicable published scientific literature. For novel sterilization methods, FDA may request additional information based on the specific device submitted for review.

The agency is conducting a webinar on Feb. 11, 2016 to help manufacturers understand the information provided in the final guidance. The agency is accepting and posting comments via Docket No. FDA-2008-D-0611.