Review of U.S. Medical Device Regulation

2007 ◽  
Vol 1 (4) ◽  
pp. 283-292 ◽  
Author(s):  
Jan B. Pietzsch ◽  
Lauren M. Aquino ◽  
Paul G. Yock ◽  
M. Elisabeth Paté-Cornell ◽  
John H. Linehan
Keyword(s):  
Medical Device ◽  
The United States ◽  
Careful Consideration ◽  
Practical Implementation ◽  
Design Development ◽  
Regulatory Requirements ◽  
Regulatory Pathways ◽  
Device Development ◽  
Federal Food ◽  
Medical Device Regulation

Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements and their practical implementation is thus an essential cornerstone of successful medical device innovation. In this paper, we review the background, mission, and statutory requirements of medical device regulation in the United States. As opposed to pharmaceuticals, which have been regulated since the early 1900s, medical device regulation was not enacted before 1976, when Congress signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act of 1938. The U.S. Food and Drug Administration (FDA) has implemented a risk-based classification system, which is essential in determining the regulatory pathway for a given device. Our review of the different regulatory pathways discusses the specific steps and requirements associated with each pathway, and their implications for development and testing of different types of devices. The differences in these pathways are significant, and thus require careful consideration and analysis already at early stages of development. The FDA’s Quality Systems Regulation, which outlines specific requirements for development, testing, production, and postmarket surveillance, is another important aspect of device regulation. We present its elements and relationship to design controls and other operating procedures implemented by device manufacturers, and discuss their relevance in ensuring the safety and effectiveness of marketed devices. A summary of recent additions to device regulation, implemented by the FDA to allow for adequate regulation of products that combine drugs and devices or biologics and devices (so-called combination products), completes our review. Because of the significance of device regulation for medical device innovation, we strongly support increased efforts to educate the various stakeholders involved in the medical device development process, both at the academic and professional level.

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.

scholarly journals Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health

J ◽  
2021 ◽  
Vol 4 (2) ◽  
pp. 206-222
Author(s):  
Marc Holfelder ◽  
Lena Mulansky ◽  
Winfried Schlee ◽  
Harald Baumeister ◽  
Johannes Schobel ◽  
...  
Keyword(s):  
Medical Device ◽  
Development Process ◽  
Regulatory Requirements ◽  
Healthcare Environment ◽  
Medical App ◽  
Regulatory Guidelines ◽  
Enormous Amount ◽  
Software Engineers ◽  
Mhealth Apps ◽  
Medical Device Regulation

Within the healthcare environment, mobile health (mHealth) applications (apps) are becoming more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the COVID-19 pandemic has led to an enormous amount of app releases. In most countries, mHealth applications have to be compliant with several regulatory aspects to be declared a “medical app”. However, the latest applicable medical device regulation (MDR) does not provide more details on the requirements for mHealth applications. When developing a medical app, it is essential that all contributors in an interdisciplinary team—especially software engineers—are aware of the specific regulatory requirements beforehand. The development process, however, should not be stalled due to integration of the MDR. Therefore, a developing framework that includes these aspects is required to facilitate a reliable and quick development process. The paper at hand introduces the creation of such a framework on the basis of the Corona Health and Corona Check apps. The relevant regulatory guidelines are listed and summarized as a guidance for medical app developments during the pandemic and beyond. In particular, the important stages and challenges faced that emerged during the entire development process are highlighted.

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