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In 2020, Illinois passed a bill requiring the Illinois Department of Public Health to triannually develop training materials for drawing blood from children and adults with intellectual and developmental disabilities and for facilities to ensure the training is incorporated for phlebotomists. [30] [31] [32]
The Illinois Department of Financial and Professional Regulation was created on July 1, 2004. It is responsible for the regulation, oversight, and licensure of almost 300 different types of professional licenses and financial institutions. The current director ("Secretary") of this department is Mario Treto, Jr.
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
The Food and Drug Administration (FDA) is the principal healthcare regulatory authority in the United States, having jurisdiction over medical devices, drugs, biologics, and combination products. The paramount objectives driving policy decisions by the FDA are safety and effectiveness of healthcare products that have to be assured through a ...
The Illinois Department of Public Health (IDPH) is the code department [2] [3] of the Illinois state government that prevents and controls disease and injury, regulates medical practitioners, and promotes sanitation. [4]
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
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