It depends.
If the IVD was approved through a Pre-Market Application (PMA), then the updated labeling needs to be submitted either in a PMA supplement (for major labeling changes) or the annual report (for minor changes) - see 21CFR814.39 and 814.84.
If the IVD was cleared through a 510(k), then the updated labeling may lead to a new 510(k) (for major labeling changes - see FDA Guidance on when to submit a new 510(k)) or could be a Letter to File (for minor labeling changes). If the 510 (k) clearance letter had a special controls statement requiring a report to the FDA for all labeling changes, then a report should be submitted to the FDA.
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Raajdeep Venkatesan RAC
US Regulatory Affairs and Quality Engineering Manager
Arlington MA
United States
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Original Message:
Sent: 06-05-2014 09:48
From: Joy Pelfrey
Subject: IVD Package Insert Revisions
Does anyone know if you are required to submit minor IVD Package insert revisions to the FDA? If so, can you tell me where the regulations are that indicate that?
Thanks!
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Joy Pelfrey
Norman OK
United States
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