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  • 1.  Product Classification Database Information

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2023 09:03
    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.



  • 2.  RE: Product Classification Database Information

    Posted 25-Jan-2023 13:22
    "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
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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  • 3.  RE: Product Classification Database Information

    Posted 25-Jan-2023 23:05
    You can read a little about the divisions here:
    https://www.fda.gov/about-fda/cdrh-offices/oht3-office-gastrorenal-obgyn-general-hospital-and-urology-devices-office-product-evaluation-and

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    Anne LeBlanc
    United States
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  • 4.  RE: Product Classification Database Information

    Posted 26-Jan-2023 04:12
    Hello,

    And to provide further comment ... the FDA is always updating and improving their systems, so some information you see on the public side of the database is new (or newer depending on when you access).  Behind-the-scenes they have the Information Technology group updating, revising, and editing information both on the log-in side as well as the public-view side.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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