With the FDA continuing to see nontraditional methods of sterilization, the agency is advising sponsors on what to include in their 510(k)s for devices labeled as sterile.
The update comes in the form of guidance titled “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.” Once final, the document would apply to 510(k)s for devices that are subject to industrial terminal sterilization processes based on microbial inactivation.
The document says the FDA is seeing a range of new methods other than steam, dry heat, radiation and ethylene oxide. “FDA has experience with other methods, such as hydrogen peroxide, ozone and flexible bag systems, and now considers them to be established methods,” according to the guidance document.
However, these newer methods are sometimes altered, and the agency has some concerns about these novel methods, as they could provide inadequate sterility assurance. To mitigate any risks, the agency says compliance with GMP should be carefully assessed. It adds that it intends to inspect a manufacturing facility before clearing a device sterilized with a novel method.
The document lists some of the novel methods the FDA has encountered, including vaporized peracetic acid, high-intensity light or pulse light, microwave radiation, sound waves and ultraviolet light.
In addition, the document recommends what specific information about these processes sponsors should include in their 510(k)s:
Issued Jan. 21, the guidance document comes a little more than seven years after the release of the draft version. It will supersede an August 2002 document titled “Updated 510(k) Sterility Review Guidance K90-1.”