www.fdanews.com/articles/113807-fda-issues-sterile-510-k-device-guidance-outlines-approval-process
FDA Issues Sterile 510(k) Device Guidance, Outlines Approval Process
January 16, 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sterilized by novel, nontraditional processes should expect an FDA inspection before getting 510(k) clearance, a new draft guidance says.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.
Novel, nontraditional sterilization methods are those for which there are no FDA-recognized standards, no FDA inspectional history, little or no published information on validation and no history of comprehensive FDA evaluation of sterilization validation data, the guidance says. Comments on the draft guidance are due by March 12.
The GMP Letter
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.
Novel, nontraditional sterilization methods are those for which there are no FDA-recognized standards, no FDA inspectional history, little or no published information on validation and no history of comprehensive FDA evaluation of sterilization validation data, the guidance says. Comments on the draft guidance are due by March 12.
The GMP Letter