Regulatory Open Forum

Have you applied Flowchart A and its supporting narratives from this FDA guidance document?

Regardless of whether a new 510(k) is required or not, the labeling change to add a warning statement is a design change that must, for a class II device, be processed per 21 CFR 820.30.  The LTF or 510(k) corresponds to the design output step of that process.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 14-Jul-2022 01:20
From: Christopher Chin
Subject: Labeling IFU changes

In reference to a Class II device, does a change to IFU, adding a warning statement, require notification to FDA even though the intended use remains unchanged?  If it doesn't require a new 510k, will a LTF suffice? 

Please advise, 

Christopher Chin

Original Message:
Sent: 7/14/2022 11:02:00 AM
From: Kevin Randall
Subject: RE: Labeling IFU changes

Have you applied Flowchart A and its supporting narratives from this FDA guidance document?

Regardless of whether a new 510(k) is required or not, the labeling change to add a warning statement is a design change that must, for a class II device, be processed per 21 CFR 820.30.  The LTF or 510(k) corresponds to the design output step of that process.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 14-Jul-2022 01:20
From: Christopher Chin
Subject: Labeling IFU changes

In reference to a Class II device, does a change to IFU, adding a warning statement, require notification to FDA even though the intended use remains unchanged?  If it doesn't require a new 510k, will a LTF suffice? 

Please advise, 

Christopher Chin

Follow the steps in the FDA guidance document Deciding When to Submit a 510(k) for a Change to an Existing Device to determine if the change requires a new 510(k). In particular, be sensitive to the potential issue of a "change being effected", CBE, 510(k) in which you make the change and notify FDA in parallel.

 

Regardless of the decision you make, document the analysis from the guidance document in the Design History File for the change.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 14-Jul-2022 01:20
From: Christopher Chin
Subject: Labeling IFU changes

In reference to a Class II device, does a change to IFU, adding a warning statement, require notification to FDA even though the intended use remains unchanged?  If it doesn't require a new 510k, will a LTF suffice? 

Please advise, 

Christopher Chin