Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff

Name: Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: approval,fda,guidances,industry,pma,pre-market,pre-market-approval,pre-market-authorization

Information

Type

Guidance

Regulated products

Biologics, Medical Devices

Topics

Premarket

Published

December 11, 2008

Last updated

February 8, 2022

Description

This document provides guidance for the decision-making process on modifications to devices subject to premarket approval (PMA).

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff

Updated on February 8, 2022

pdf (680.2KB)

URL: https://www.fda.gov/media/81431/download
Permalink: https://data.openrid.co/en/datasets/r/89a73173-62b7-423e-acf2-99b9975077ab
MIME Type: application/pdf

Created on: December 11, 2008
Modified on: February 8, 2022

Size: 680.2KB

Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff

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Regulated products

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Last updated

Description

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