Updating the Indications for Use meant reformatting and merging source documents into a single, consistent structure, work that looks cosmetic right up until a reviewer rejects it for exactly that reason.
Cosmetic until it's a rejection reason
Fonts, structure, and document merging read as purely cosmetic concerns, but a submission built to the wrong format can be rejected on that basis alone, independent of the accuracy of its content.
- Comparing the existing checklist/instruction against the current regulation or process in practice
- Correcting discrepancies found during that comparison
- Confirming the update against the source document or QMS procedure
What an outdated instruction risks
An outdated checklist or work instruction being followed after the underlying regulation or process has changed is the exact failure mode this update was checked against.
What the update delivered
Reformatting and merging the documents into the required standard made the Indications for Use package submission-ready.
The Real Takeaway
Formatting and merging documents seems purely cosmetic but is often a submission requirement in its own right.
Getting it wrong is a preventable reason for rejection.