Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

Premarket Review of Medical Devices in the United States

2000 ◽  
Vol 7 (3) ◽  
pp. 293-326
Author(s):  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Regulatory System ◽  
The United States ◽  
The Public ◽  
The World ◽  
Contemporary Perspective ◽  
Premarket Approval ◽  
The U.S ◽  
Medical Device Regulation

AbstractIt has been sixty years since the Congress first authorized FDA to regulate medical devices. During this period, countless studies, reports, and investigations have been targeted at medical devices. The law has been significantly modified several times, and the regulations revised on numerous occasions. As for any other scheme of administration or management, revisions are necessary as demand arises for legislative attention to societal risks, the economy fluctuates, and when businesses expand and globalize. Studying the U.S. system of medical device regulation merely from a contemporary perspective fails to take into account the significance of decades of effort in maintaining the quality and integrity of the system in an ever-changing field of medical device regulation.The three-pronged medical device regulatory system that entails inspection of manufacturing facilities, premarket approval, and postmarket recall and reporting enables the public to benefit from medical devices without the fear of unreasonable risk with their use (Appendix 1). President Clinton proudly pronounced the following in a 1995 speech:Today, Americans don't have to worry about safety or effectiveness when they buy [drugs and medical devices] - from cough syrups to the latest antibiotics or pacemakers. The Food and Drug Administration has made American drugs and medical devices the envy of the world and in demand all over the world. And we are going to stick with the standards we have - the highest in the world.…^218

A Regulatory Overview of Hip And Knee Joint Replacement Devices

2019 ◽  
Vol 6 (3) ◽  
pp. 212-230
Author(s):  
Anmol Wadhwa ◽  
Sushama Talegaonkar ◽  
Harvinder Popli
Keyword(s):  
United States ◽  
Knee Joint ◽  
Medical Device ◽  
Joint Replacement ◽  
The United States ◽  
Regulation System ◽  
Knee Joint Replacement ◽  
New Findings ◽  
Post Market ◽  
Medical Device Regulation

Objective: Medical device acceptance of patients has grown considerably in recent years. This has question the effectiveness of the current regulatory frameworks to ensure the performance, safety, and quality of new devices. This article focuses on the methodical overview on hip and knee joint replacement medical devices evaluating the procedure and proper analysis of medical device regulation in three jurisdictions i.e. the United States of America (USA), EUROPE and INDIA, exploring reforms been laid to stabilize and meet the requirements of existing systems, and further analyse the additional actions which should be employed to fully meet this ultimate goal. Method: We analysed the hip and knee joint replacement medical device regulation system through a secondary research in United States, Europe and India in compliance with the updated national regulatory authority’s legislative documents and requirements. Result: These three regulatory systems vary in their working, organization, acceptance for their specific pre- and post-market evidence requirements, and transparency of process. The most challenging factor remains the same for the countries which are to make sure safety and effectiveness of devices, proper monitoring of its use and important compliance information readiness employing quality management system towards new findings and acceptance for the users. A case study of Johnson & Johnson ASR Implant was also studied, highlighting the major reforms required and the reforms introduced in the United States, Europe and India. Thus, quality and safety reforms are made to strengthen the premarket compliance requirements, enhancing the need of post-market regulation through proper traceability and monitoring of devices by employing the functioning medical device registry. Conclusion: Recent reforms address the major challenges in device regulation, highlighting the need to create connecting points between the device identifier system and existing data collection tools, such as electronic health records, and maintaining effective and up to date use of registries to ensure post-market use of new and existing devices.

An Assessment of the EU Approach to Medical Device Regulation against the Backdrop of the US System

2010 ◽  
Vol 1 (2) ◽  
pp. 137-149
Author(s):  
Bernhard Lobmayr
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Medical Condition ◽  
Regulatory Systems ◽  
Information Time ◽  
The Us ◽  
European System ◽  
Government Involvement ◽  
The Eu ◽  
Medical Device Regulation

A medical device is intended to alleviate a medical condition or to substitute a body function. The use of medical devices entails risks, first and foremost for patients who usually lack the necessary information, time and ability for informed decisions. Based on this, societies choose to regulate these products. Government involvement in medical device regulation seems to be more pronounced and centralised in the US than it is in the EU, where the system involves privatised elements. A consultation, initiated by the European Commission in 2008, proposed at its centre the introduction of a European medical device agency. By this the European system would follow the US benchmark. This research discusses some fundamental questions pertaining to the risk concept in medical devices, namely how risks are currently being addressed in the two most important regulatory systems of the US and the EU, and how the European system might be adjusted in the future.

scholarly journals Analyzing the Factors Affecting the COVID-19 Risk Level in the US Counties

2021 ◽  
Author(s):  
Samira Ziyadidegan ◽  
Moein Razavi ◽  
Homa Pesarakli ◽  
Amir Hossein Javid
Keyword(s):  
United States ◽  
Rural Areas ◽  
Pearson Correlation ◽  
The United States ◽  
Positive Case ◽  
Risk Level ◽  
Classification Models ◽  
Factors Affecting ◽  
The Us ◽  
Us Counties

The COVID-19 disease spreads swiftly, and nearly three months after the first positive case was confirmed in China, Coronavirus started to spread all over the United States. Some states and counties reported an extremely high number of positive cases and deaths, while some reported too few COVID-19 related cases and mortality. In this paper, the factors that could affect the transmission of COVID-19 and its risk level in different counties have been determined and analyzed. Using Pearson Correlation, K-means clustering, and several classification models, the most critical ones were determined. Results showed that mean temperature, percent of people below poverty, percent of adults with obesity, air pressure, percentage of rural areas, and percent of uninsured people in each county were the most significant and effective attributes.

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