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Intro -- MEDICAL DEVICES AND THE FDA REGULATION, USER FEES AND TORT CLAIMS -- MEDICAL DEVICES AND THE FDA REGULATION, USER FEES AND TORT CLAIMS -- CONTENTS -- PREFACE -- Chapter 1 FDA REGULATION OF MEDICAL DEVICES -- SUMMARY -- INTRODUCTION -- THE MEDICAL DEVICE REVIEW PROCESS: PREMARKET REQUIREMENTS -- Device Classification -- Medical Device Marketing Applications -- 510(k) Notification -- Premarket Approval (PMA) -- THE MEDICAL DEVICE REVIEW PROCESS: POST-MARKET REQUIREMENTS -- Labeling -- Manufacturing -- Postmarketing Surveillance -- Postmarket Surveillance -- Adverse Event Reporting -- Medical Device Tracking -- The Sentinel Initiative -- Unique Device Identification -- Compliance and Enforcement -- Inspection -- Warning Letter -- Product Recall -- APPENDIX A. HISTORY OF LAWS GOVERNING MEDICAL DEVICE REGULATION -- The Federal Food, Drug and Cosmetics Act of 1938 -- The Medical Device Amendments of 1976 -- The Safe Medical Devices Act of 1990 -- The Food and Drug Administration Modernization Act of 1997 -- User Fee Acts and the FDA Amendments Act of 2007 -- APPENDIX B. ACRONYMS USED IN THIS REPORT -- End Notes -- Chapter 2 THE FDA MEDICAL DEVICE USER FEE PROGRAM -- SUMMARY -- INTRODUCTION -- CURRENT LAW -- FDA Premarket Review of Medical Devices -- Medical Device User Fees -- Exemptions and Discounted Fees -- Use of User Fees -- Other MDUFA Requirements -- MDUFA IMPACT ON FDA REVIEW TIME AND BUDGET -- MDUFA III PROPOSAL -- Draft Legislative Language -- Draft Industry-FDA Performance Goals and Procedures for MDUFA III: The Agreement -- Process Improvements -- Review Performance Goals -- Shared Outcome Goals -- Infrastructure -- Independent Assessment of Review Process Management -- Performance Reports -- Discretionary Waiver -- Other Potential Issues -- APPENDIX A. PROVISIONS IN FFDCA 737 AND 738

Medical devices and equipment are a vital component of patient care. From a simple tongue depressor to a sophisticated haemodialysis machine, medical devices are needed at every level of the health service. Yet many health services continue to lack information and financial resources to acquire the devices they really need, i.e. those that will address the specific disease burden in their country. Effective implementation of a National Regulatory Authority is a first step towards the cost-effective management of medical devices that meet international quality and safety standards, throughout t

Cover -- Half-Title -- T itle -- Copyright -- Description -- Contents -- Chapter 1: Introduction -- Chapter 2: CSR Initiatives of Governmental or Intergovernmental Bodies -- Chapter 3: Sectoral CSR Commitments -- Chapter 4: CSR-Related Reporting and Management Standards -- Chapter 5: Securities Exchanges and Regulators -- Chapter 6: CSR-Related Nonprofits and NGOs -- About the Author -- Index -- Adpage -- Backcover.

An international symposium on Medical Care and Protection of Prisoners and Detainees was organized by the Ciba Foundation, in London, from 27 to 30 November 1972. The papers read at the symposium and the discussions which followed related mainly to minimum rules governing the treatment of all detainees, provisions made by various governments regarding hygiene, care, food, etc., and the role of the doctor in that domain. The texts were compiled and assembled in a volume published some time ago.The book contains a study essentially based on the experiences of ICRC delegates which will undoubtedly be of particular interest to readers. It was written by the late Pierre Boissier, and we wish to thank the Ciba Foundation for allowing us to reproduce it. (Ed.)

Labour standards have become an almost routine feature of trade agreements. However, we have little knowledge about whether this linkage is effective; both in absolute terms but also in comparison to other instruments that promote labour standards on a global level. Such alternative instruments include public-private agreements, value chain management and procurement policies. The articles in this thematic issue will provide insights that further the debate on the effectiveness of the connection between labour rights and international trade, looking at both 'traditional' trade agreements and 'alternative' instruments.

PharmD ; The spectrum of medical device regulation worldwide is diverse. The safety of the patient takes centre stage whenever updates are made to any regulation. In Europe, the Medical Device Directives were reviewed due to scandals like the one that involved leaking silicone breast implants that contained a different grade of silicone than was initially approved. This led to the development of the Medical Device Regulation (EU 2017/745- MDR), which due to the corona virus pandemic will come into force in May 2021 and not May 2020. Africa does not have a standard medical device regulation. Many countries in Africa do not have country specific medical device regulations and implement varied regulatory practices. The purpose of this study was to evaluate the regulations and guidelines for medical devices in Europe (Germany and Switzerland) and five countries in Africa, namely, Uganda, Kenya, Tanzania, Rwanda and Ghana with the aim of identifying gaps and proposing strategies for improvement. A questionnaire was administered to 15 regulatory officers and a key informant guide used to interview 5 key informants. Questionnaires were self-administered and the key informant interviews conducted via telephone, skype and face to face. Data analysis of audio interviews, transcripts and notes based on qualitative thematic content was conducted and reviewed for consistency for qualitative data. Questionnaires were used to carry out quantitative data triangulation of the interviews. Challenges reported by the participants included inadequate staff numbers which was common to all the African authorities, existence of an imbalance between pre-market approval and post market surveillance with more emphasis being placed on pre-market activities. Neglect of post market surveillance due to lack of funds to conduct related activities. Perception on the robustness of the medical device regulation was mixed, for example, Tanzania reported that the regulatory system is not robust enough to guarantee medical device safety, effectiveness and quality as inspection of manufacturing facilities is not done and the approach applied was based on the pharmaceutical regulatory framework. The African countries that took part in this study have undertaken several measures including formulation of regulations where none exist, revisions to medical device regulations to cater for advances in technology and categories of medical devices not taken into consideration at the time the regulations were developed, recruitment of qualified staff and a harmonization drive through the Pan African Harmonisation Work Party to develop a standard regulation for medical devices. The results of this study provide a current picture and better understanding of the status of medical device regulations and guidelines applied in Europe and the selected African countries. Regulation of medical devices in Africa is limited and the participating African countries were at different maturity levels with respect to existence of medical device regulation, guidelines and actual practice. Out of the 5 African countries that participated, 3, namely, Kenya, Rwanda and Uganda lacked regulations. The absence of a regulatory framework for medical device regulation in the 3 countries implies that the scope of regulation is ill defined. Harmonisation efforts for medical device regulation are in the early stages implying that the development of a standard regulation lacks a defined timeline. This thesis could contribute to advances in medical device regulation as the results demonstrated that the ground is fertile for the development of regulations where none exist, can contribute towards harmonization efforts and aid in adoption of improvements in regulation where they exist. This will bolster regulatory efforts and contribute towards patient access to safe and effective medical devices of good quality. ; N/A

A major obstacle to establishing a computer-stored medical record is the lack of "standards" that would permit government, care providers, insurance companies, and medical computer system developers to share patient data easily. In this position paper, the Board of Directors of the American Medical Informatics Association recommends specific approaches to standardization in the areas of patient, provider, and site of care identifiers; computerized health care message exchange; medical record content and structure, and medical codes and terminologies. The key concept developed in this position paper is that developers and users of computer-stored medical records must embrace existing and tested approaches, despite their imperfections, to progress quickly. This approach to standardization is being coordinated with the American National Standards Institute's Health Informatics Standards Planning Panel. The development of standards is a long-term process involving continued refinement. The proposed standards are an important step toward the goal of better and more efficient health care.