30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff

Name: 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: approval,changes,exemptions,fda,guidances,humanitarian,industry,manufacturing,notices,pma,pre-market,pre-market-approval,pre-market-authorization

Information

Type

Guidance

Regulated products

Biologics, Medical Devices

Topics

Administrative / Procedural, Premarket

Published

December 16, 2019

Last updated

January 26, 2021

Description

This document provides guidance for industry and FDA staff on 30-day notices, PMA supplements, and HDE supplements for manufacturing changes.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff

Updated on January 26, 2021

pdf (135.3KB)

URL: https://www.fda.gov/media/72663/download
Permalink: https://data.openrid.co/en/datasets/r/09e49515-707d-4142-b385-7c7a4b22c058
MIME Type: application/pdf

Created on: December 16, 2019
Modified on: January 26, 2021

Size: 135.3KB

30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

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