Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff

Name: Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: annual-report,applications,approval,fda,guidances,industry,pma,pre-market,pre-market-approval,pre-market-authorization,reporting

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Administrative / Procedural, Premarket

Published

December 16, 2019

Last updated

October 20, 2020

Description

This document is a guidance document titled "Annual Reports for Approved Premarket Approval Applications (PMA)" for industry and FDA staff. It covers administrative/procedural and premarket topics.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff

Updated on October 20, 2020

pdf (146.1KB)

URL: https://www.fda.gov/media/73391/download
Permalink: https://data.openrid.co/en/datasets/r/610a5abe-715d-4c09-9957-2e33415160e7
MIME Type: application/pdf

Created on: December 16, 2019
Modified on: October 20, 2020

Size: 146.1KB

Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

License

Feedback

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