title: Cardiac resynchronization devices: the Food and Drug Administration's regulatory considerations.
abstract: Cardiac resynchronization therapy (CRT) devices have been studied clinically since 1998, and have been on the U.S. market since the Food and Drug Administration (FDA) approval of the first product in 2001. Since that time, the FDA has approved many different models from three different manufacturers, representing the first and second generations of these products. All of these products have undergone the FDA pre-market approval process, which examines the safety and effectiveness of the devices for their intended use. Over the last several years, the FDA has adapted recommendations for CRT clinical trials based on an evolving understanding of what these devices can achieve. This paper will outline the dynamic nature of the FDA's approval process for CRT devices and briefly review the clinical trial designs for the first generation devices.
authors.affiliation: Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Maryland 20850, USA. megan.moynahan@fda.hhs.gov
authors.forename: Megan
authors.initials: M
authors.lastname: Moynahan
authors.forename: Owen P
authors.initials: OP
authors.lastname: Faris
authors.forename: Brian M
authors.initials: BM
authors.lastname: Lewis
mesh_terms: D020811:Biomedical Technology / Q000639:trends; D002303:Cardiac Output, Low / Q000628:therapy*; D002986:Clinical Trials as Topic; D018795:Device Approval; D006801:Humans; D010138:Pacemaker, Artificial / Q000009:adverse effects / Q000592:standards; D011358:Product Surveillance, Postmarketing; D012107:Research Design