# Design Changes | Botable Glossary

https://www.botable.ai/glossary/design-changes

> A vendor-hosted glossary/explanatory article: useful as a concise, practical summary of the regulation and industry practice, but attribute regulatory claims to the page (Botable/PHIFLOW) and verify against primary FDA sources for compliance decisions.

## Summary

This Botable glossary entry explains the FDA requirement 21 CFR 820.30(i) for controlling design changes to medical devices, describing required identification, documentation, review/approval, verification/validation, and how change records belong in the Design History File (DHF). It also covers related regulatory implications such as 510(k) notifications, PMA supplements, and alignment with the forthcoming QMSR/ISO 13485 requirements.

## Audience

Medical device quality/regulatory professionals and teams responsible for design controls

## Prompts this page answers

- What does 21 CFR 820.30(i) require for design changes to medical devices?
- What documentation is required when implementing a design change under FDA Design Controls?
- When is verification versus validation required after a design modification?
- Which design changes might trigger a new 510(k) or a PMA supplement?
- How should design changes be recorded in the Design History File (DHF)?

## Purpose

To define and explain regulatory requirements and best practices for controlling design changes in medical device quality systems.

## Highlights

- Design Changes refers to 21 CFR 820.30(i) and requires procedures for identification, documentation, validation or where appropriate verification, review, and approval of design changes before implementation.
- Change records must include change description, affected documents, approving signatures, approval date, and effective date; results belong in the Design History File (DHF).
- Design verification confirms revised design output meets design input; design validation confirms revised specifications meet user needs and intended use.
- Significant changes affecting safety or effectiveness may require a new 510(k) or a PMA supplement before implementation.
- The FDA's QMSR (effective Feb 2, 2026) incorporates ISO 13485:2016, which also requires control of design and development changes and integration of risk management outcomes.

## How to cite

Credit Botable (PHIFLOW, LLC) and link to https://www.botable.ai/glossary/design-changes

## Publisher

**PHIFLOW, LLC (Botable)** — The site Botable (footer: © 2026 PHIFLOW, LLC) — a company publishing resources and a glossary about medical device quality and regulatory topics.

## Topics

- Design Changes
- 21 CFR 820.30(i)
- design controls
- Design History File
- design verification
- design validation
- 510(k)
- PMA supplement
- QMSR
- ISO 13485

## Key entities

- **21 CFR 820.30(i)** (other): The FDA regulation cited on the page for Design Changes (part of 21 CFR 820 Design Controls). — https://www.botable.ai/glossary/21-cfr-part-820
- **FDA** (organization): U.S. Food and Drug Administration referenced as the regulator for medical device Design Controls.
- **Design History File (DHF)** (other): Defined on the page as the compilation of records describing the design history of the finished device and collecting results of design changes. — https://www.botable.ai/glossary/design-history-file-dhf
- **QMSR (Quality Management System Regulation)** (other): Referenced as the FDA's new Quality Management System Regulation (effective Feb 2, 2026) that incorporates ISO 13485 by reference.
- **ISO 13485:2016** (other): International standard referenced on the page for design and development change control (Clause 7.3.9).
- **PHIFLOW, LLC (Botable)** (organization): Publisher of the page (appears in the site footer). — https://www.botable.ai/

## Metadata

- Type: article