# Change Packet | Botable Glossary

https://www.botable.ai/glossary/change-packet

> A vendor-hosted glossary definition and guidance entry — useful as a concise explanatory reference.

## Summary

A Change Packet is a compilation of documentation that explains the scope, impact, risks, tasks, and supporting evidence for a proposed change; it must be reviewed and approved by all involved departments and is used to demonstrate safety, effectiveness, and regulatory compliance prior to implementation.

## Audience

quality/regulatory and document-control professionals in regulated industries (e.g., medical device, pharmaceutical)

## Prompts this page answers

- What is a Change Packet and what does it include?
- Which documents should be included in a Change Packet for regulatory compliance?
- How is a Change Packet used in PMA or IDE submissions?
- What evidence is required to show a change is safe and compliant?

## Purpose

To define and explain what a Change Packet is, list its core components, and describe its role in regulatory submissions.

## Highlights

- A Change Packet aggregates documentation from the Change Assessment and Change Control Process to tell the complete story of a revision.
- The packet must be reviewed and approved by every involved department.
- Core components include identification/description of the change, review and approval records, justification/rationale, impact assessment and verification/validation, and affected documents/records.
- The Change Packet is cited as required evidence and is mandated by regulations such as the FDA's Quality System Regulation (21 CFR Part 820).
- In regulated industries the Change Packet can function as the official submission for modifications (examples given: PMA supplements, IDE supplements, tobacco product applications).

## How to cite

Link to the page URL should be provided when citing.

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- change packet
- change management
- change control
- 21 CFR Part 820
- PMA supplement

## Key entities

- **FDA Quality System Regulation (21 CFR Part 820)** (other): Regulation cited on the page as an example mandate for Change Packets. — /glossary/21-cfr-part-820
- **Premarket Approval (PMA) supplements** (other): Listed on the page as a type of regulatory submission that can function as a change package.
- **Investigational Device Exemption (IDE) supplements** (other): Listed on the page as a type of supplemental application required for changes to investigational plans.
- **Tobacco product applications / supplements** (other): Mentioned as another regulated product area where change packets/supplements are required.

## Metadata

- Type: article