ABSTRACT
The Food and Drug Administration (FDA) is classifying the diurnal pattern recorder system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the diurnal pattern recorder system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Subject(s)
Device Approval/legislation & jurisprudence , Diagnostic Techniques, Ophthalmological/classification , Diagnostic Techniques, Ophthalmological/instrumentation , Ophthalmology/classification , Ophthalmology/instrumentation , Equipment Safety/classification , Humans , Intraocular Pressure , Monitoring, Physiologic/classification , Monitoring, Physiologic/instrumentation , Telemetry/classification , Telemetry/instrumentation , United StatesABSTRACT
This review aims to discuss and summarize the evidence base for devices that have a role in monitoring patients with heart failure for the purpose of attempting to prevent heart failure-related admissions. Despite contemporary heart failure service provision, many patients continue to need acute admission for decompensation. There is a clinical need for a better strategy for predicting decompensation earlier so that appropriate therapeutic interventions can be commenced sooner in order to prevent the need for acute hospital admission. Between clinical assessment visits, the contemporary approach to management is based primarily on daily home monitoring of weight by patients; while this has proved useful, it falls short. For example, substantial weight gain was seen in only 20% of ADHF admission patients according to data collected in the TEN-HMS home telemonitoring study. Monitoring devices offer the possibility of tracking additional physiological or haemodynamic parameters that may allow for earlier detection and more accurate identification of patients at risk of acute decompensation.
Subject(s)
Biomedical Technology , Heart Failure/physiopathology , Patient Readmission , Telemedicine , Telemetry/classification , Early Diagnosis , Hemodynamics , HumansABSTRACT
The Food and Drug Administration (FDA) is classifying the ingestible telemetric gastrointestinal capsule imaging system device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
