Hello,
Quick question which may require a complicated answer...
If a physician were to reprocess a SUD (validation reports including testing and limitations in-house), would he/she need to register as a reprocessor with FDA? Per FDA guidance on reprocessing, it is only applicable to hospitals and third-party processors, not individual physicians.
Also, if the device is labeled as SUD, could he/she be liable for adulterating a device by reprocessing?
Thank you!
Gretchen
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Gretchen Upton RAC
RA/QA
TX
United States
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