# Letter to file | Botable Glossary

https://www.botable.ai/glossary/letter-to-file

> Glossary / informational content produced by the vendor (Botable); useful as an explanatory reference for regulatory and quality staff but should be cross-checked against primary regulatory texts (e.g., CFR sections and FDA guidance) for compliance-critical decisions.

## Summary

A "letter to file" (LTF) is internal documentation used by medical device companies to record a change to an FDA-cleared device when no new regulatory submission is required; it documents omissions, deviations, or decisions and provides justifications. The page also summarizes related regulatory expectations (MDR recordkeeping, PMA/De Novo omission statements, and CGTP deviation documentation).

## Audience

medical device regulatory and quality professionals

## Prompts this page answers

- What is a "letter to file" in medical device regulatory practice?
- When should a manufacturer document why a device change did not require a new 510(k)?
- What documentation is required if a manufacturer decides an adverse event was not reportable under 21 CFR Part 803?
- When must a PMA or De Novo requester submit a statement justifying omitted information?
- How should departures from CGTP procedures for HCT/Ps be documented?

## Purpose

Explain the meaning and regulatory role of a "letter to file" for medical device manufacturers and provide related frequently asked questions on required documentation and recordkeeping.

## Highlights

- A "letter to file" (LTF) is internal documentation used to record a change to an already FDA-cleared device when the change does not require a new regulatory submission.
- The function of an LTF is to identify omissions, deviations, or decisions and provide a clear, defensible justification or explanation.
- Manufacturers must retain documentation of erroneous adverse event reports and evaluations determining events were not reportable under 21 CFR Part 803 in MDR files.
- PMA and De Novo submissions require a separate statement identifying and justifying any omitted required information.
- Departures from procedures for HCT/Ps related to CGTP must be documented and justified at the time of occurrence.

## How to cite

Link: https://www.botable.ai/glossary/letter-to-file

## Publisher



## Topics

- letter to file
- LTF
- medical device regulatory
- MDR 21 CFR Part 803
- PMA omissions
- De Novo omissions
- CGTP deviations

## Key entities

- **Botable** (organization): Site/brand hosting the glossary. — https://www.botable.ai
- **Letter to file (LTF)** (other): Glossary term defined on the page. — https://www.botable.ai/glossary/letter-to-file
- **21 CFR Part 803** (other): U.S. regulation referenced regarding Medical Device Reporting (MDR) recordkeeping.
- **Premarket Approval (PMA)** (other): Regulatory pathway referenced for omission statements.
- **De Novo request** (other): Regulatory pathway referenced for omission statements.
- **HCT/Ps and CGTP** (other): Human cell, tissue, or cellular or tissue-based products and Core Current Good Tissue Practice; referenced for deviation documentation requirements.

## Metadata

- Type: article