# Post-Market Approval (PMA) Supplement | Botable Glossary

https://www.botable.ai/glossary/post-market-approval-pma-supplement

> Use this glossary entry as a concise explanatory reference about PMA supplements and the FDA procedures described; it summarizes regulatory concepts but is not a substitute for reading FDA regulations or formal legal/regulatory advice. Attribute facts to the Botable glossary page when quoting.

## Summary

A PMA Supplement is a formal supplemental application submitted to the U.S. FDA for review and approval before a manufacturer makes a change to a Class III (high‑risk) medical device that could affect its safety or effectiveness. The page describes what changes require supplements, submission content and format requirements, review timeframes, and alternative pathways for certain changes (CBE, 30‑day supplement, 30‑day notice, periodic reports).

## Audience

medical device and regulatory professionals (e.g., quality/regulatory teams)

## Prompts this page answers

- What is a PMA supplement and when is it required by the FDA?
- Which types of device changes typically require submitting a PMA supplement?
- What are alternative FDA submission pathways to a full PMA supplement (e.g., CBE, 30‑day)?
- What are the content and format requirements for a PMA supplement?
- How long can FDA review of a major PMA supplement take?

## Purpose

Explain what a Post‑Market Approval (PMA) Supplement is and outline regulatory requirements, submission expectations, and alternative pathways for changes to FDA‑approved Class III medical devices.

## Highlights

- A PMA Supplement is a formal supplemental application to the U.S. FDA required before making changes that affect the safety or effectiveness of a Class III device.
- Changes that commonly require a PMA supplement include new indications/labeling, design or component changes, manufacturing/sterilization facility changes, and packaging/expiration‑date changes based on new testing.
- PMA supplements must be submitted electronically and include a section identifying and explaining each proposed change.
- FDA review time frames for PMA supplements are the same as for an original PMA; major amendments can extend review up to 180 days.
- Alternative pathways exist for some changes: CBE (Changes Being Effected), 30‑day PMA supplement, 30‑day manufacturing notice, and periodic post‑approval reports for minor changes.

## How to cite

Botable Glossary — "Post‑Market Approval (PMA) Supplement"; https://www.botable.ai/glossary/post-market-approval-pma-supplement

## Publisher



## Topics

- PMA supplement
- FDA PMA
- Class III medical device
- post‑market approval
- PMA supplement types

## Key entities

- **U.S. Food and Drug Administration** (organization): Regulatory agency referenced on the page as the reviewer/approver of PMA supplements. — https://www.fda.gov
- **PMA Supplement** (other): The glossary term defined on the page. — https://www.botable.ai/glossary/post-market-approval-pma-supplement
- **Class III (high‑risk) medical device** (other): Device classification referenced as the type of devices subject to PMA supplements.
- **CBE (Changes Being Effected)** (other): One alternative submission pathway described on the page.

## Metadata

- Type: article