FDA Issues Long-Planned Draft Guidance On Functional Indications For ICDs
This article was originally published in The Gray Sheet
Executive Summary
Manufacturers who wish to describe the benefits of ICDs in a particular patient population in the device labeling must submit a PMA supplement to FDA with supporting data, according to a 1draft guidance
You may also be interested in...
ICD Function, Patient Population Claims Will Be Clarified By CDRH Guidance
FDA is crafting a "functional indications" policy to help agency staff and implantable cardioverter defibrillator manufacturers clarify the devices' intended patient population
ICD Promotion For New Indications May Not Need PMA Supplements - FDA
FDA would still need to consider on a case-by-case basis whether a premarket approval application supplement would be required for manufacturers to promote new indications for implantable cardioverter defibrillators (ICDs) under the agency's proposed labeling change for the devices.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.