Hello,
I am looking for any advise or thoughts on regulatory (submission and GMP) requirements for collecting biohazard SUD, removing programmed circuit board from cleaned SUD (note: circuit board is non/contact and is enclosed separately from pathways that are required to be sterile) and reusing in a new SUD with all new components except circuit board.
Device is Class II (US). Class Is (EU).
I am questioning if a submission is required if cleaning validation of biohazard SUD is sufficient, and concludes additional sterilization re-validation (for status of sterility) is not required? or if testing for life span over numerous sterilization cycles would automatically trigger a 510k? Also wondering if re-registering as "reprocessor" and updating device listing would trigger a disconnect, if submission not completed? Thank you in advance.
Melanie
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Melanie Hess
VP, Regulatory Affairs
Osprey Medical
Rogers MN
United States
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