As this device is not in direct contact with a patient, (i.e. it is similar to using one's eye or a camera against the lens of the endoscope -- means that are already being used) to my understanding there is not a need for FDA approval.
Thanks,
nick
Nicholas Hellenthal, MD
Resident Physician
Department of Urology
University of California at Davis
Comments
Dr. Hellenthal,
Can you please elaborate on the status of FDA approvals for this device. Does it fall under the perview of the FDA at all?
Thanks
Prashant
Hi Prashant,
As this device is not in direct contact with a patient, (i.e. it is similar to using one's eye or a camera against the lens of the endoscope -- means that are already being used) to my understanding there is not a need for FDA approval.
Thanks,
nick
Nicholas Hellenthal, MD
Resident Physician
Department of Urology
University of California at Davis
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