FDA Issues New Guidance in Response to HRS Device Performance Recommendations
On July 19, 2007 the FDA announced new Guidance for Industry and FDA staff titled Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs) (Download Adobe PDF, 64K)
In response to the Heart Rhythm Society's Device Performance Recommendations, this Guidance Document aims to standardize communications to implanting physicians while helping physicians, other health professionals, and patients make the appropriate decision for each patient about:
- explanting the device,
- reprogramming it, or
- taking a "watch and wait" approach.
Joel Harder, Director of Quality Improvement and Outcomes, is the staff representative and can be reached at 202-464-3489 or jharder@hrsonline.org, should you have any questions.
