Regulatory Affairs Certification (RAC) Practice Exam

Which action should NOT be taken after receiving a vote of "non-approvable" from an FDA Advisory Panel?

1. Continue marketing the device for its Class II classification

2. Update the current labeling to include the new indication

3. Proceed with a PMA submission to FDA

4. Request a post-panel meeting with the FDA

The correct answer is: Update the current labeling to include the new indication

The action that should not be taken after receiving a vote of "non-approvable" from an FDA Advisory Panel is the update of current labeling to include the new indication. When an Advisory Panel votes non-approvable, it indicates that the panel has identified significant issues or deficiencies with the product, which precludes the approval of the new indication. Therefore, any attempt to update the labeling would be inappropriate, as it would suggest that the device is approved for that indication when it is not. In this context, continuing marketing the device for its existing Class II classification, proceeding with a PMA submission, and requesting a post-panel meeting with the FDA are actions that can be taken. Continuing to market a device already classified as Class II is permissible unless the marketing is directly tied to the indication that was non-approvable. A PMA submission could still be explored if there is sufficient data supporting the product, independent of the non-approvable indication. Lastly, requesting a post-panel meeting can provide valuable feedback from the FDA on how to address the panel's concerns and potentially find a pathway to approval in the future.