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GUIDANCE DOCUMENT

Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs) Guidance for Industry and FDA Staff July 2007

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.