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

Issue Date: July 19, 2007
Issued by: Center for Devices and Radiological Health
Topic(s): Postmarket, Radiological Health
Status: Final

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

This guidance provides best practices for manufacturers when drafting and issuing Dear Doctor letters to disseminate information about significant health hazards to users of implantable cardioverter defibrillators (ICDs). This guidance may also be used by FDA in reviewing manufacturers’ Dear Doctor letters prior to their issuance. This guidance includes recommendations for technical content, formatting, and use of risk communication principles. These letters may also be titled Dear Health Care Professional when they are disseminated beyond the direct physician community.

Download the Guidance Document