FDA Calls Customized Reporting Forms For Heart Devices “Impractical”
This article was originally published in The Gray Sheet
Executive Summary
FDA will not act on a key recommendation from the Heart Rhythm Society that the agency develop a customized form for reporting adverse events involving implantable cardioverter defibrillators (ICDs) and pacemakers
You may also be interested in...
Industry And FDA Question Key Heart Rhythm Society Recommendations
Device industry stakeholders do not support a key recommendation from the Heart Rhythm Society that the National Cardiovascular Data Registry be modified to collect more patient follow-up data on the performance of implantable cardioverter defibrillators (ICDs) and pacemakers
Heart Rhythm Society Calls On Industry, FDA To Overhaul Device Surveillance
Draft recommendations from the Heart Rhythm Society would increase the clarity and amount of information industry gives FDA, physicians and patients on pacemaker and implantable cardioverter defibrillator (ICD) performance
FDA Unveils Medical Device “Postmarket Transformation”
FDA's device center is establishing a senior-level team of agency staffers and outside experts to lead an effort to revitalize the postmarket device safety program, the agency announced Jan. 19