Code of Federal Regulations
Author:
Publisher:
Published: 2007
Total Pages: 1096
ISBN-13:
DOWNLOAD EBOOKSpecial edition of the Federal register. Subject/agency index for rules codified in the Code of Federal Regulations, revised as of Jan. 1 ...
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Public Health Effectiveness of the FDA 510(k) Clearance Process
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2010-10-04
Total Pages: 141
ISBN-13: 0309162904
DOWNLOAD EBOOKThe 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.
Title 21 Food and Drugs Parts 800 to 1299 (Revised as of April 1, 2014)
Author: Office of The Federal Register, Enhanced by IntraWEB, LLC
Publisher: IntraWEB, LLC and Claitor's Law Publishing
Published: 2014-04-01
Total Pages: 843
ISBN-13: 016092345X
DOWNLOAD EBOOKThe 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.
Code of Federal Regulations, Title 21, Food and Drugs, Pt. 800-1299, Revised As of April 1 2015
Author: Food and Drug Administration (U S )
Publisher: Office of the Federal Register
Published: 2015-04-01
Total Pages: 862
ISBN-13: 9780160928048
DOWNLOAD EBOOKThis 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;
Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration
Author: United States. Food and Drug Administration
Publisher:
Published: 1989
Total Pages: 92
ISBN-13:
DOWNLOAD EBOOKThe Medical-Legal Aspects of Acute Care Medicine
Author: James E. Szalados
Publisher: Springer Nature
Published: 2021-04-02
Total Pages: 694
ISBN-13: 3030685705
DOWNLOAD EBOOKThe 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.
2018 CFR Annual Print Title 21 Food and Drugs Parts 800 to 1299
Author: Office of The Federal Register
Publisher: IntraWEB, LLC and Claitor's Law Publishing
Published: 2018-04-01
Total Pages: 945
ISBN-13: 164024316X
DOWNLOAD EBOOK3D Printing in Medicine
Author: Frank J. Rybicki
Publisher: Springer
Published: 2017-09-27
Total Pages: 139
ISBN-13: 3319619241
DOWNLOAD EBOOKThis 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.
Code of Federal Regulations, Title 21, Food and Drugs, Pt. 800-1299, Revised as of April 1, 2011
Author: Office Of Federal Registry National Archives And Records Administration
Publisher: Government Printing Office
Published: 2011-05-25
Total Pages: 808
ISBN-13: 9780160884016
DOWNLOAD EBOOKMedical Instrument Design and Development
Author: Claudio Becchetti
Publisher: John Wiley & Sons
Published: 2013-07-29
Total Pages: 612
ISBN-13: 1119952409
DOWNLOAD EBOOKThis book explains all of the stages involved in developing medical devices; from concept to medical approval including system engineering, bioinstrumentation design, signal processing, electronics, software and ICT with Cloud and e-Health development. Medical Instrument Design and Development offers a comprehensive theoretical background with extensive use of diagrams, graphics and tables (around 400 throughout the book). The book explains how the theory is translated into industrial medical products using a market-sold Electrocardiograph disclosed in its design by the Gamma Cardio Soft manufacturer. The sequence of the chapters reflects the product development lifecycle. Each chapter is focused on a specific University course and is divided into two sections: theory and implementation. The theory sections explain the main concepts and principles which remain valid across technological evolutions of medical instrumentation. The Implementation sections show how the theory is translated into a medical product. The Electrocardiograph (ECG or EKG) is used as an example as it is a suitable device to explore to fully understand medical instrumentation since it is sufficiently simple but encompasses all the main areas involved in developing medical electronic equipment. Key Features: Introduces a system-level approach to product design Covers topics such as bioinstrumentation, signal processing, information theory, electronics, software, firmware, telemedicine, e-Health and medical device certification Explains how to use theory to implement a market product (using ECG as an example) Examines the design and applications of main medical instruments Details the additional know-how required for product implementation: business context, system design, project management, intellectual property rights, product life cycle, etc. Includes an accompanying website with the design of the certified ECG product (www.gammacardiosoft.it/book) Discloses the details of a marketed ECG Product (from Gamma Cardio Soft) compliant with the ANSI standard AAMI EC 11 under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses (upper-level undergraduate and graduate students) and for engineers interested in medical instrumentation/device design with a comprehensive and interdisciplinary system perspective.
