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The WCD was extensively tested for three years in 17 major medical centers across the United States and Europe. The clinical data collected from those trials [26] allowed Lifecor to obtain FDA approval for use of the WCD in the United States. [citation needed] In 2001, the FDA approved the LifeVest wearable cardioverter defibrillator (model 2000).
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
An automated external defibrillator or automatic electronic defibrillator (AED) is a portable electronic device that automatically diagnoses the life-threatening cardiac arrhythmias of ventricular fibrillation (VF) and pulseless ventricular tachycardia, [1] and is able to treat them through defibrillation, the application of electricity which stops the arrhythmia, allowing the heart to re ...
A picture of Medtronic's Aurora EV-ICD, or extra vascular internal cardiac defibrillator, pictured Thursday, Dec. 28, 2023, at the Sparrow Thoracic Cardiovascular Institute.
Right-to-try laws are United States state laws and a federal law created with the intent to allow terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but not been approved by the Food and Drug Administration (FDA). Before right-to-try laws, patients needed FDA approval to use ...
In April 2009, Citation Technologies created a free, searchable website for Federal Register articles dating from 1996 to the present. [ 7 ] GovPulse.us, [ 8 ] a finalist in the Sunlight Foundation's Apps for America 2, [ 9 ] provided a Web 2.0 interface to the Federal Register , including sparklines of agency activity and maps of current rules ...
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.