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Post-traumatic stress disorder (PTSD) may develop following exposure to an extremely threatening or horrific event.It is characterized by several of the following signs or symptoms: unwanted re-experiencing of the traumatic event—such as vivid, intense, and emotion-laden intrusive memories—dissociative flashback episodes, or nightmares; active avoidance of thoughts, memories, or reminders ...
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.
CFR Title 42 - Public Health is one of fifty titles comprising the United States Code of Federal Regulations (CFR). Title 42 is the principal set of rules and regulations issued by federal agencies of the United States regarding public health, including respirator rules and regulations moved from CFR Title 30 (including MSHA), to the Public Health Service (including NIOSH and the CDC).
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]
Medical device cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness of the device. Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment ...
The CFR annual edition is published as a special issue of the Federal Register by the Office of the Federal Register (part of the National Archives and Records Administration) and the Government Publishing Office. [1] In addition to this annual edition, the CFR is published online on the Electronic CFR (eCFR) website, which is updated daily.
Mental health-related legal concepts include mens rea, insanity defences; legal definitions of "sane," "insane," and "incompetent;" informed consent; and automatism, amongst many others. Statutory law usually takes the form of a mental health statute. An example is the Mental Health Act 1983 in England and Wales. These acts codify aspects of ...
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.