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Reporting Electronic Product Radiation Defects - use 21CFR1003 or 21CFR806 to report?

  • 1.  Reporting Electronic Product Radiation Defects - use 21CFR1003 or 21CFR806 to report?

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jan-2023 08:15
    This message was posted by a user wishing to remain anonymous

    Our company has always reported recalls related to FDA subpart J using the 21CFR1003 reporting requirements.  I have discovered that others have reported all recalls whether for Electronic Product Radiation Defects or not under the 21CFR806 reporting requirements.

    Can anyone here help me understand if 21CFR806 takes precedence over 21CFR1003 when reporting recalls related to radiation issues, and where that is documented in the Act.

    Please explain how these reporting requirements work together.


  • 2.  RE: Reporting Electronic Product Radiation Defects - use 21CFR1003 or 21CFR806 to report?

    Posted 31-Jan-2023 12:15
    Edited by Rajeswari Devanathan 31-Jan-2023 12:32

    Hi, 
    21CFR806 and 21CFR1003 have to be followed together. 
    § 1003.5 Effect of regulations on other laws.

    The remedies provided for in this subchapter shall be in addition to and not in substitution for any other remedies provided by law and shall not relieve any person from liability at common law or under statutory law.





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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
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