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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).
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
[1] [2] The Title 21 amendments were signed into law on May 28, 1976, by the 38th President of the United States Gerald R. Ford. [3] The U.S. legislation enacted in 1976 amended the Food, Drug, and Cosmetic Act of 1938 signed by the 32nd President of the United States Franklin D. Roosevelt. [4]
Citation Technologies offers the complete Federal Register and Code of Federal Regulations (CFRs) through subscription-based web portals such as CyberRegs. [13] HeinOnline (1936–): Full coverage available dating back to 1936 in an image-based searchable PDF format. LexisNexis (July 1, 1980–): Searchable text format since 45 FR 44251.
In the law of the United States, the Code of Federal Regulations (CFR) is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent broad areas subject to federal regulation.
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 ...
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 ...
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.