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The Affordable Health Care for America Act (or HR 3962) [1] was a bill that was crafted by the United States House of Representatives of the 111th United States Congress on October 29, 2009. The bill was sponsored by Representative Charles Rangel. At the encouragement of the Obama administration, the 111th Congress devoted much of its time to ...
Health care portal. v. t. e. The American Health Care Act of 2017 (often shortened to the AHCA or nicknamed Ryancare) was a bill in the 115th United States Congress. The bill, which was passed by the United States House of Representatives but not by the United States Senate, would have partially repealed the Affordable Care Act (ACA).
Medical device reporting ( MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report ...
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.
Executive Order 13813 [1] [2] [3] President Trump signing the Executive Order, October 12, 2017. The Executive Order Promoting Healthcare Choice and Competition, also known as the Trumpcare Executive Order, or Trumpcare, [4] [5] is an Executive Order signed by Donald Trump on October 12, 2017, which directs federal agencies to modify how the ...
No. 20-219, 596 U.S. ___ (2022) The Affordable Care Act ( ACA ), formally known as the Patient Protection and Affordable Care Act ( PPACA) and colloquially as Obamacare, is a landmark U.S. federal statute enacted by the 111th United States Congress and signed into law by President Barack Obama on March 23, 2010.
Signed into law by President George H. W. Bush on November 28, 1990. Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act. The Act mandates reporting requirements by medical device manufacturers regarding adverse ...
An investigational device exemption ( IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510 (k)] submission to Food and Drug Administration (FDA). [2]