Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration Staff

Name: Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: approval,enforcement,exemptions,fda,guidances,humanitarian,industry,pma,policies,pre-market,pre-market-approval,pre-market-authorization,submissions

Information

Type

Guidance

Regulated products

Biologics, Medical Devices

Topics

Premarket

Published

November 2, 2023

Last updated

November 1, 2023

Description

This document is a guidance for industry and FDA staff on the enforcement policy for certain supplements for premarket approval submissions.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration Staff

Updated on November 1, 2023

pdf (474.0KB)

URL: https://www.fda.gov/media/138265/download
Permalink: https://data.openrid.co/en/datasets/r/c1c07927-47d7-453c-8157-cfdcf065c483
MIME Type: application/pdf

Created on: November 2, 2023
Modified on: November 1, 2023

Size: 474.0KB

Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: 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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