Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff

Name: Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff
Creator: Food and Drug Administration
Keywords: cdrh,center-for-devices-and-radiological-health,fda,guidances,industry,meetings,modernization,pre-market

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Investigational Device Exemption (IDE), Premarket

Published

February 27, 2001

Last updated

August 10, 2023

Description

This document provides guidance on early collaboration meetings under the FDA Modernization Act, focusing on IDE and premarket topics.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

1 Main file

Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff

Updated on August 10, 2023

pdf (79.7KB)

URL: https://www.fda.gov/media/71676/download
Permalink: https://data.openrid.co/en/datasets/r/4e1d2966-99ab-46f8-b73d-061f66d7f2be
MIME Type: application/pdf

Created on: February 27, 2001
Modified on: August 10, 2023

Size: 79.7KB

Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

Actions

Social networks

Embed