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Safety standards for clinical diagnostic ultrasonic devices were developed for use in relatively low-frequency systems (1-10 MHz), under the assumption that non-linear effects would be negligible. Thi...
Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the ...
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable...
In order to compare the radiation immunity test level of ISO 14708 series standards and the domestic and international environmental radiation standards and then to ascertain whether the radiated immu...
The field of medicine has been rapidly changing recently for providers and patients. This article considers how such changes have impacted the roles and responsibilities of the medical facility radiat...
Background: - Cord blood transplants can treat cancers and other diseases in children and adults. The U.S. Food and Drug Administration (FDA) requires cord blood to be collected and store...
That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internation...
This study evaluates the level of agreement between visual parameters tested using OdySight, a mobile application, and standards in office methods.
Purpose: To establish the prevalence of anticoagulant, aspirin, and clopidogrel use in patients undergoing vitreoretinal surgery, and to compare the outcome of peribulbar anesthesia betwee...
Postoperative pain (POP) is frequently underestimated in general and little data are available particularly for POP after vitreoretinal surgery (VRS). The investigators will conduct a 1-ye...
An office in the Department of Labor responsible for developing and establishing occupational safety and health standards.
An institute of the CENTERS FOR DISEASE CONTROL AND PREVENTION which is responsible for assuring safe and healthful working conditions and for developing standards of safety and health. Research activities are carried out pertinent to these goals.
Standards or regulations for construction which are designed to ensure safety against electrical hazards, fires, etc.
Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.