Letter to file

A "letter to file" (LTF) is internal documentation used by medical device companies to record a change to an already FDA-cleared device when that change does not require a new regulatory submission

The function of a Letter to File is a documented statement or record, internal to the organization or contained within a submission file, that identifies specific omissions, deviations, or decisions, and provides a clear, defensible justification or explanation for that action or lack of action.

Regulatory framework frequently requires manufacturers and applicants to generate and maintain internal written justifications or statements that serve the functional purpose of a Letter to File: providing documented explanations for omissions, decisions not to act, or departures from procedures.

Frequently Asked Questions (FAQs) Associated with Internal Justification Documentation

1. When must documentation be maintained to explain a decision not to report an adverse event?

For Medical Device Reporting (MDR) purposes (21 CFR Part 803), if a manufacturer, importer, or user facility receives information regarding an adverse event but determines that the event did not occur (i.e., the information is erroneous), they must retain documentation of these reports in their MDR files for specified time periods.

Furthermore, if a manufacturer evaluates a device-related event and determines it was not reportable under 21 CFR Part 803, they must document and maintain in their MDR event files an explanation of why they did not submit or could not obtain any information required by that part. The results of the evaluation of each event must also be documented and maintained in the MDR event files.

2. When is a statement required to justify the omission of information in a submission?

In the context of premarket submissions to the FDA, detailed justification is required if mandatory information is left out:

• Premarket Approval Application (PMA) Omissions: If an applicant omits information required for a PMA submission (under § 814.20(b)) because they believe it is not applicable to the device, the applicant shall submit a statement that identifies the omitted information and justifies the omission. This statement must be submitted as a separate section in the PMA and identified in the table of contents.
• De Novo Request Omissions: Similarly, if a requester omits certain required information from a De Novo request, the requester must submit a statement that specifies the omitted information and justifies the omission. If the justification for the omission is not accepted by FDA, the agency will notify the requester.

3. What documentation is required for deviations from established procedures?

For establishments handling Human Cell, Tissue, or Cellular or Tissue-Based Products (HCT/Ps) that relate to Core Current Good Tissue Practice (CGTP) requirements, the organization must document and justify any departure from a procedure at the time of its occurrence.

4. Who is responsible for reviewing and maintaining this justification documentation?

For medical device manufacturers, the results of the evaluation of each event (which would include justifications for non-reporting) must be maintained in the MDR event files. These MDR event files must clearly identify all documentation of the manufacturer's deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable. If the manufacturer’s designated complaint unit is separate from the manufacturing establishment, the records of investigation must be reasonably accessible to the manufacturing establishment.

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