FDA Gives ‘Best Practices’ for Dear Doctor Letters on ICDs
Implantable cardioverter defibrillators (ICDs) are life-saving devices whose failures can cause patient deaths, and communication of these failures to healthcare professionals requires a “specialized approach,” the FDA says in a recent guidance. The guidance outlines what the agency considers “best practices” for communicating with healthcare professionals about ICD failures.
The document guides manufacturers on the content, format and risk communication principles of Dear Doctor letters regarding ICD failures, corrections or removals. It may also be used by the FDA in reviewing manufacturers’ Dear Doctor letters prior to their issuance.
When device failures involve ICDs in distribution, the manufacturer should initiate a recall, correction or removal with oversight by the FDA, according to the guidance. It should notify all consignees, including physicians, of the reason for recall and the suggested actions to correct or minimize patient risk.
The guidance, “Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs),” can be accessed at www.fda.gov/cdrh/ocer/guidance/1645.pdf.