Code of Federal Regulations

Code of Federal Regulations
Author:
Publisher:
Total Pages: 1096
Release: 2007
Genre: Administrative law
ISBN:

Special edition of the Federal register. Subject/agency index for rules codified in the Code of Federal Regulations, revised as of Jan. 1 ...

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 141
Release: 2010-10-04
Genre: Medical
ISBN: 0309162904

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.

3D Printing in Medicine

3D Printing in Medicine
Author: Frank J. Rybicki
Publisher: Springer
Total Pages: 139
Release: 2017-09-27
Genre: Medical
ISBN: 3319619241

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

The Medical-Legal Aspects of Acute Care Medicine
Author: James E. Szalados
Publisher: Springer Nature
Total Pages: 694
Release: 2021-04-02
Genre: Medical
ISBN: 3030685705

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.

Title 21 Food and Drugs Parts 800 to 1299 (Revised as of April 1, 2014)

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
Total Pages: 843
Release: 2014-04-01
Genre: Law
ISBN: 016092345X

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.

Countering the Problem of Falsified and Substandard Drugs

Countering the Problem of Falsified and Substandard Drugs
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 377
Release: 2013-06-20
Genre: Medical
ISBN: 0309269393

The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.