"DHT3C" in this case is the organizational abbreviation for FDA's
Division of Health Technology 3 C. That is FDA's CDRH OPEC group responsible for the premarket review of the subject device.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 24-Jan-2023 16:34
From: Anonymous Member
Subject: Product Classification Database Information
This message was posted by a user wishing to remain anonymous
Previously when reviewing product classifications in the database the portion circled in red did not appear under premarket review. Does anyone know when this was added? Does this mean anything additional other than compliance with the most recent human factors guidance? Assuming it appears for all product codes with premarket review? Does the DHT3C mean anything significant? Thanks in advance for the insight.