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For a PMA submission, the FDA determines whether the device is safe and effective, based on the data provided by the sponsor.
The hospital said it did not know whether the device, a bronchoscope, was at fault.
Device Shared Whether the device is shared, as reported by the device owner.
Encryption Status Whether the device has been encrypted, as reported by its management system.
Compliance Status Whether the device complies with the University's security mandate.
Device Encrypted Whether the device has been encrypted, as reported by its management system.
Some readers questioned whether the device was legal to use on planes at all.
Access Prohibited Data Whether the device owner can access Prohibited Data, as reported by the device owner.
Ownership Whether the device is owned by Stanford or is a personal device, as reported by the device owner.
Access Restricted Data Whether the device owner can access Restricted Data, as reported by the device owner.
Device Exception Whether the device has an exception to the encryption requirement, as reported by the Exception Request system.
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CEO of Professional Science Editing for Scientists @ prosciediting.com