Description
Taylor & Francis The Medical Device Industry Science Technology and Regulation in a Competitive Environment 1990 Edition by Norman F. Estrin
Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach Table of contents :- "Introduction Focus on Patient Care Historic Overview/Legal Framework of the Regulatory Environment A History of Government Regulation of Adulteration and Misbranding of Medical Devices Medical Device Regulation: The Big Picture FDA's Regulatory Program for Medical Devices Overview of Current FDA Requirements for Product Approvals Responding as Organizations to the Regulatory Environment CDRH's Medical Device Laboratories The FDA's Role in Assisting Small Manufacturers Precautionary Checklist for Addressing the Issue of Medical Device User Error and Product Misuse FDA's Role in Medical Device User Education Industry's Role in Standards Development Role of NCCLS and ECCLS in the Voluntary Consensus Process Role of AAMI in the Voluntary Standards Process Role of ECRI Role of ASTM in the Voluntary Standards Process Role of USP Responding as Companies to the Regulatory Environment How to Submit a Successful 510(k) Compiling a Successful PMA Application Optimal Use of FDA Advisory Panels Complying with the IDE Regulation Clinical Trials and Labeling Claims Establishing a Training Program for Plant Personnel Complying with GMPs: Government Perspective Complying with GMPs: Industry Perspective Developing a Recall Program Complying with the Medical Device Reporting Regulation FDA/GMP/MDR Inspections: Obligations and Rights Product Liability Implications of Regulatory Compliance or Noncompliance Developing a Labeling Compliance Program Home Use Diagnostics: Special Considerations Sterility and Bioburden: An Issue for In Vitro Diagnostic Products Current and Emerging Issues in the Regulatory Environment Process/Design/Facility Validation Use of Risk Assessment Procedures for Evaluating Risks of Ethylene Oxide Residues in Medical Devices Medical Device Risk Assessment The AIDS Epidemic: Its Impact on Manufacture and Use of Medical Devices The Animal Testing Issue New Challenges in Medical Product Sterilization Legislation Needed to Improve the Medical Devices Law The 1989 Waxman/Dingell Medical Devices Bill Software Regulation Maintaining Your Competitive Edge at Home and Abroad Accessing New Technologies: The Federal Connection Responding to the Challenge of Education of Nurses and Allied Health Personnel on the Safe Use of Medical Devices Historic Overview/Legal Framework of Occupational and Environmental Safety and Health An Overview of Regulations Governing Occupational Exposure Right-to-Know Regulations Safe Handling of Biologically Contaminated Medical Devices Current and Emerging Issues in Occupational and Environmental Safety and Health Government Initiatives in the Environmental and Occupational Safety and Health Arena Historic Overview/Legal Framework of Coverage, Payment, and Marketing Medicare's Policy Perspective on Coverage and Payment for Medical Technology The Impact of Cost Control in Restructuring of the Health-Care Industry The Structure of the Medicare Program: Legal Considerations of HCFA Regulation Basics of Medicare Payment for Hospital and Physician Services Payment Planning for New Medical Diagnostics: An Action Plan for the 1990s Medical Standard Setting in the Current Malpractice Environment: Problems and Possibilities Afterword Responding as Companies to Coverage, Payment, and Marketing Understanding and Securing Medicare Coverage for New Medical Technology Avoiding Fraud and Abuse Complying with Antitrust/FTC Restrictions Current and Emerging Issues in Coverage, Payment, and Marketing Megamarketing: An Expanded Approach for the 1990s Historical Overview/Legal Framework of the International Environment Trends in International Regulations and Their Growing Impact U.S. and Foreign Requirements: A Legal Overview Responding as Organizations to International Issues Industry Role in International Standards Networking Internationally Economics of U.S. Trade in Medical Technology and Export Promotion Activities of the U.S. Trade in Medical Technology and Export Promotion Activities of the U.S. Department of Commerce Responding as Companies to International Issues Using Partnerships and Other Joint Ventures Current and Emerging Issues in the International Environment An Overview of the European Community's 1992 Program ANSI---Its Role in the Rapidly Changing Marketplace "