Video FAQs

What are some tips from RQM+ former FDA CDRH and SMEs on good letter to file documentation? 

Start with FDA Guidance, "Deciding when to submit a 510(k) for a change to an existing device" and follow it closely. In your letter to file, provide detail of your changes, and document a strong justification and your best argument for why your justification is adequate. Do not just create a checklist from the guidance and check the boxes that apply. It's much harder to defend your decision in an audit if the letter to file contains only checked boxes rather than details of why the decision was made. And include engineering level detail in the justification. Also remember that the letter to file should be based upon cumulative changes since the submission. Be very cautious of cumulative changes, and as regulatory, take a stance when it's time to submit.