title: Regulatory issues for computerized electrocardiographic devices.
abstract: Computerized electrocardiogram (ECG) devices are regulated in the U.S. by the FDA Center for Devices and Radiological Health (CDRH). This article aims to highlight the salient points of the FDA regulatory review process, including the important distinction between a "tool" claim and a "clinical" claim in the intended use of a computerized ECG device. Specifically, a tool claim relates to the ability of the device to accurately measure a certain ECG parameter, such as T-wave alternans (TWA), while a clinical claim imputes a particular health hazard associated with the identified parameter, such as increased risk of ventricular tachyarrhythmia or sudden death. Given that both types of claims are equally important and receive the same regulatory scrutiny, the manufacturer of a new ECG diagnostic device should consider the distinction and regulatory pathways for approval between the two types of claims discussed in this paper.
authors.affiliation: Department of Health and Human Services, Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, MD, USA. neal.muni@fda.hhs.gov
authors.forename: Neal I
authors.initials: NI
authors.lastname: Muni
authors.forename: Charles
authors.initials: C
authors.lastname: Ho
authors.forename: Elias
authors.initials: E
authors.lastname: Mallis
mesh_terms: D016757:Death, Sudden, Cardiac / Q000517:prevention & control; D018795:Device Approval; D004562:Electrocardiography / Q000295:instrumentation*; D004867:Equipment Design; D004869:Equipment Safety; D033161:Government Regulation; D006801:Humans; D018570:Risk Assessment; D012815:Signal Processing, Computer-Assisted / Q000295:instrumentation*; D012984:Software; D017180:Tachycardia, Ventricular / Q000175:diagnosis; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*