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The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Special edition of the Federal register. Subject/agency index for rules codified in the Code of Federal Regulations, revised as of Jan. 1 ...
The Code of Federal Regulations Title 21 contains the codified Federal laws and regulations that are in effect as of the date of the publication pertaining to food and drugs, both legal pharmaceuticals and illegal drugs.
This book describes the fundamentals of three-dimensional (3D) printing, addresses the practical aspects of establishing a 3D printing service in a medical facility, and explains the enormous potential value of rendering images as 3D printed models capable of providing tactile feedback and tangible information on both anatomic and pathologic states. Individual chapters also focus on selected areas of applications for 3D printing, including musculoskeletal, craniomaxillofacial, cardiovascular, and neurosurgery applications. Challenges and opportunities related to training, materials and equipment, and guidelines are addressed, and the overall costs of a 3D printing lab and the balancing of these costs against clinical benefits are discussed. Radiologists, surgeons, and other physicians will find this book to be a rich source of information on the practicalities and expanding medical applications of 3D printing.
The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a comprehensive resource intended to provide a state-of-the-art overview of complex ethical, regulatory, and legal issues of importance to clinical healthcare professionals in the area of acute care medicine; including, for example, physicians, advanced practice providers, nurses, pharmacists, social workers, and care managers. In addition, this book also covers key legal and regulatory issues relevant to non-clinicians, such as hospital and practice administrators; department heads, educators, and risk managers. This text reviews traditional and emerging areas of ethical and legal controversies in healthcare such as resuscitation; mass-casualty event response and triage; patient autonomy and shared decision-making; medical research and teaching; ethical and legal issues in the care of the mental health patient; and, medical record documentation and confidentiality. Furthermore, this volume includes chapters dedicated to critically important topics, such as team leadership, the team model of clinical care, drug and device regulation, professional negligence, clinical education, the law of corporations, tele-medicine and e-health, medical errors and the culture of safety, regulatory compliance, the regulation of clinical laboratories, the law of insurance, and a practical overview of claims management and billing. Authored by experts in the field, The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a valuable resource for all clinical and non-clinical healthcare professionals.
This print ISBN is the U.S. Federal Government Official edition of this title. 21 CFR Parts 800 to 1299 covers the U. S. Food and Drug Administration within the U.S. Department of Health and Human Services. Within this volume, you will find rules, procedures, and regulations pertaining to medical devices, such as cardiovascular devices, dentistry devices, orthopedic, gastroenterology-urology, in vitro, anestheology, and more. Plus, you will find rules, procedures, and regulations relating to mammography quality standards, radiological health, tobacco products, human tissue intended for transplantation, and more. Keywords: health care; healthcare; healthcare policy; medical devices; healthcare personnel; hospital personnel; physicians; out-patient clinical staff; medical technicians; cigarette tobacco and advertising, smoking; tobacco; food and drug administration; fda; FDA; united states food and drug administration; united states department of health and human services; HHS; hhs; medical technology; 21 CFR Parts 800-1299; cfr 21 parts 800-1299; cfr 21 Parts 800-1299; 21 CFR; 21 cfr; 21 code of federal regulations;