Documentation

This is often called a 'letter to file'. Each decision point and the final conclusion should be recorded, with any test results referenced, because FDA can ask to see the rationale during an inspection.

For the purpose of this guidance, documentation means recording the rationale behind the manufacturer’s decision whether to submit a new 510(k) for changes in a device. Consideration of each decision point should be recorded, as well as the final conclusions reached. If testing or other engineering analysis is part of the process, the results of this activity should be recorded or referenced. A copy of this documentation should be maintained for future reference.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology