Medical Devices; 510(k) Sterility Change Master File Pilot Program

Issuing agencies

Abstract

The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its 510(k) Sterility Change Master File Pilot Program ("510(k) Sterility Pilot Program"). The 510(k) Sterility Pilot Program is voluntary and intends to give interested companies that terminally sterilize single- use devices ("sterilization providers") using certain sterilization methods a pathway to submit a Master File for FDA's review. FDA will accept a Master File into the 510(k) Sterility Pilot Program when it determines, among other things, that there is not a likelihood that switching from a fixed chamber ethylene oxide (EtO) sterilization method to the sterilization method described in the Master File could significantly affect the safety or effectiveness of a 510(k)-cleared device that meets the product definition in the Master File and that satisfies other conditions outlined in this document. If a Master File is accepted into the 510(k) Sterility Pilot Program, manufacturers of 510(k)-cleared devices ("510(k) holders") may choose to reference the Master File in internal documentation in support of a justification for not submitting a new premarket notification (510(k)) under certain conditions as outlined in this document. This voluntary pilot program seeks to encourage industry to consider new, innovative ways to sterilize devices that reduce the potential impact of EtO on the environment and on public health, while ensuring consistent patient access to safe devices and providing a framework for future regulatory approaches that would help address potential device shortages related to EtO sterilization.