FDA Says PCCPs Are Possibility For Sterilization Changes
During its third EtO town hall, the CDRH brought up the possibility of approving predetermined change control plans for device sterilization changes.
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Vaporized Hydrogen Peroxide Moved To Established Category A, And Other Updates From FDA’s EtO Town Hall
A US FDA town hall explained the vaporized hydrogen peroxide category update and set the stage for a series of meetings to come.
The US FDA’s Center for Devices and Radiological Health has announced the guidance documents it plans to focus on in fiscal year 2024, and this time, AI devices make the cut.
New cybersecurity regulations passed as part of the year-end omnibus bill included software bills of materials (SBOMs) which will provide visibility to manufacturers and regulators.