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In the European Union, the European Medicines Agency has jurisdiction and the relevant documents are called the "summary of product characteristics" (SPC or SmPC) and the document for end-users is called the "patient information leaflet" or "package leaflet". The SPC is not intended to give general advice about treatment of a condition but does ...
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
Whiplash, whose formal term is whiplash associated disorders (WAD), is a range of injuries to the neck caused by or related to a sudden distortion of the neck [1] associated with extension, [2] although the exact injury mechanisms remain unknown. The term "whiplash" is a colloquialism. "Cervical acceleration–deceleration" (CAD) describes the ...
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.
The Consumer Safety Act (CPSA) was enacted on October 27, 1972, by the United States Congress.The act should not be confused with an earlier Senate Joint Resolution 33 of November 20, 1967, which merely established a temporary National Commission on Product Safety (NCPS), and for only 90-days (at a pittance of $100 per day).
Medical device cannot be classified as a class I device because the controls authorized are insufficient to provide reasonable assurance of the safety and effectiveness of the device. Medical device has sufficient information to establish a performance standard and it is necessary to establish a performance standard for the device.
Pages for logged out editors learn more. Contributions; Talk; Whiplash injury
Head restraint in a Lincoln Town Car. Head restraints (also called headrests) are an automotive safety feature, attached or integrated into the top of each seat to limit the rearward movement of the adult occupant's head, relative to the torso, in a collision — to prevent or mitigate whiplash or injury to the cervical vertebrae.