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.com3470 Superior Court
Oakville ON L6L0C4
Canada
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Original Message:
Sent: 30-Jan-2023 03:50
From: Anonymous Member
Subject: Reporting Electronic Product Radiation Defects - use 21CFR1003 or 21CFR806 to report?
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.