Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs): Guidance for Industry and FDA Staff

Information

Type

Guidance

Regulated products

Medical Devices, Radiation-Emitting Products

Topics

Postmarket

Published

July 19, 2007

Last updated

March 19, 2020

Description

This document provides guidance for writing Dear Doctor Letters for recalls of Implantable Cardioverter Defibrillators (ICDs).

Organization

Country / Region

United States

License

Other (Public Domain)

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