FDA Issues Sterile 510(k) Device Guidance, Outlines Approval Process

January 13, 2009
Manufacturers of devices sterilized by novel, nontraditional processes should expect an FDA inspection before getting 510(k) clearance, a new draft guidance says. The draft, intended to update and clarify the procedures for reviewing 510(k)s for sterile devices, applies to devices subject to an industrial terminal sterilization process based on microbial inactivation — such as radiation, steam and ethylene oxide.
The GMP Letter