FDA issues draft guidance on submissions for sterile devices
Device Regulation Alert: Safety, Compliance and Reimbursement News, December 29, 2008
The FDA updated and clarified in new draft guidance the procedures for reviewing pre-market notification submissions [510(k)s] for devices labeled as sterile.
The guidance provides details about the pyrogenicity information manufacturers should include in 510(k) submissions and provides information about the sterilization processes recommended by the FDA. It includes information about traditional, non-traditional, and novel non-traditional sterilization methods.
The guidance does not cover the sterilizers themselves or 510(k) submissions for reusable medical devices, 510(k) submissions for reprocessed single-use devices, or information to be included in 510(k)s for devices that contain animal tissue.
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