scholarly journals The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

2018 ◽  
Author(s):  
Anna Reifschneider
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
The United States ◽  
Biological Evaluation ◽  
Regulatory Affairs ◽  
Risk Management Process ◽  
Master's Thesis ◽  
Guidance Documents ◽  
The U.S

The U.S. Food and Drug Administration ("FDA") regulates all medical devices in the United States. As part of its regulatory duties, the FDA provides guidance documents on various regulatory topics as mandated by the U.S. code of federal regulations. Since 2015, the FDA has begun to issue many substantial revisions to their guidance documents that directly affects the regulatory framework on biocompatibility, reprocessing, and sterilization.These regulatory issues are of paramount importance for many companies because of the potential high costs involved in changing their internal design, controls, manufacturing, and quality systems. This master’s thesis examines the various changes made by the FDA in recent years on the inter-related topics of biocompatibility, reprocessing, and sterilization. Some of the major changes by the FDA involve an increase in the importance of chemical characterization, a reduction in the use of animal testing, a requirement for an independent validation of the user instructions for reusable devices, and increased usability testing.The principal reasons for these major policy changes by the FDA are shown to be the major device scandals that recently involved duodenoscopes, metal-on-metal hip implants, and vaginal surgical mesh implants. Along with several other regulatory failures that made national news headlines in the United States, the FDA began to revise several of their previous medical device guidances. The information from this master’s thesis can be used by medical device developers and manufacturers, especially when they are located outside of the United States and lack sufficient regulatory affairs resources to provide independent advice and recommendations on these important FDA changes. A thorough analysis is made of the new FDA guidances to clarify several potentially difficult questions for medical device manufacturers, specifically the following: (1) "Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", (2) "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", and (3) "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". This master’s thesis is intended to provide not only an overview of the current FDA requirements, but to function as a guide for both researchers and engineers to improve their medical device design and development process.

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.

Chemicals Policy in the United States—The Need for New Directions

2014 ◽  
Author(s):  
Joel A. Tickner
Keyword(s):  
United States ◽  
Medical Devices ◽  
The United States ◽  
Product Safety ◽  
Toxic Chemicals ◽  
Consumer Product ◽  
Toxic Substances ◽  
Consumer Product Safety ◽  
Chemicals Policy ◽  
The U.S

The system for regulating toxic substances in the United States is broken. It is disjointed and reactionary, lacking in information, authority, and primary prevention. The case study of bisphenol A (BPA) demonstrates a myriad of limitations with the way we evaluate, regulate, and manage toxic substances in society. The purpose of this chapter is to provide a brief overview of the current U.S. system for regulating toxic chemicals and to identify limits in that approach with particular emphasis on BPA. It provides an overview of some of the drivers shaping new approaches to chemicals regulation and management and a framework for designing more precautionary and solutions-stimulating policies in the future. The U.S. system for regulating toxic chemicals in production systems and products is relatively complex. Different types of chemicals are regulated in various ways in the U.S. system, depending on how that chemical is being used. For example, cosmetics, chemicals used in food applications, medical devices, and pharmaceuticals are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetics Act, and each of these types of chemical applications is regulated differently under the Act. For chemicals used in cosmetic products, the FDA has no premarket authority and can regulate a chemical ingredient only if it is mis­branded or adulterates the product. In the case of new food contact substances and uses of them (indirect food additives including chemicals that might leach out of packaging such as bottles), manufacturers are required to submit notifications, including safety data, to the FDA, except when a substance is previously regulated or considered “generally recognized as safe” because earlier evidence on that material did not indicate concerns. At the FDA, the highest evidentiary burdens are for medical devices and pharmaceuticals that have strong premarket testing requirements to ensure safety and efficacy. Chemicals in many consumer products, such as toys, are regulated by the U.S. Consumer Product Safety Commission (CPSC) under the Consumer Product Safety Improvement Act and the Federal Hazardous Substances Act.

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

US Perspectives on the EU Medical Device Approval System, and Lessons Learned from the United States

2013 ◽  
Vol 4 (4) ◽  
pp. 443-464
Author(s):  
Christa Altenstetter
Keyword(s):  
United States ◽  
European Union ◽  
Medical Devices ◽  
The United States ◽  
Interdisciplinary Studies ◽  
Lessons Learned ◽  
Science Literature ◽  
The European Union ◽  
The U.S ◽  
The Eu

The literature on the regulation of drugs at the FDA and the European Union is substantial, yet little research has provided comparative analyses and robust empirical data on the regulation of medical devices in the United States and the European Union. As medical and health markets become increasingly globalized, and the U.S. and the EU compete for leadership and recognition, salient domestic regulatory issues are becoming increasingly international and transnational policy issues. Building on Carpenter's (2010) work on drug regulation at the FDA, but taking a slightly narrower yet at the same time a broader approach by drawing on interdisciplinary studies instead of limiting ourselves to only the Political Science literature, this comparison focuses on key aspects of risk regulation and governance of medical devices in the U.S. and the EU, and shows how and why individual and organizational learning is imperative in each case.

scholarly journals Mapping the genealogy of medical device predicates in the United States

PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0258153
Author(s):  
Dhruv B. Pai
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Product Life Cycle ◽  
De Novo ◽  
Infusion Pump ◽  
The United States ◽  
Substantial Equivalence ◽  
Specific Product

Background In the United States, medical devices are regulated and subject to review by the Food and Drug Administration (FDA) before they can be marketed. Low-to-medium risk novel medical devices can be reviewed under the De Novo umbrella before they can proceed to market, and this process can be fairly cumbersome, expensive, and time-consuming. An alternate faster and less-expensive pathway to going to market is the 510(k) pathway. In this approach, if the device can be shown to be substantially equivalent in safety and effectiveness to a pre-existing FDA-approved marketed device (or “predicates”), it can be cleared to market. Due to the possibility of daisy-chaining predicate devices, it can very quickly be difficult to unravel the logic and justification of how a particular medical device’s equivalence was established. From patients’ perspective, this minimizes transparency in the process. From a vendor perspective, it can be difficult to determine the right predicate that applies to their device. Methods We map the connectivity of various predicates in the medical device field by applying text mining and natural language processing (NLP) techniques on data publicly made available by the FDA 78000 device summaries were scraped from the US FDA 510(k) database, and a total of 2,721 devices cleared by the 510(k) regulatory pathway in 2020 were used as a specific case study to map the genealogy of medical devices cleared by the FDA. Cosine similarity was used to gauge the degree of substantial equivalence between two medical devices by evaluating their device descriptions and indications for use. Recalls and complaints for predicate devices were extracted from the FDA’s Total Product Life Cycle database using html scraping and web page optical character recognition to determine the similarity between class 1 recalled devices (the most severe form of device recall) and other substantially equivalent devices. A specific product code was used to illustrate the mapping of the genealogy from a De Novo device. Results and discussion The ancestral tree for the medical devices cleared in 2020 is vast and sparse, with a large number of devices having only 1–2 predicates. Evaluation of substantial equivalence data from 2003–2020 shows that the standard for substantial equivalence has not changed significantly. Studying the recalls and complaints, shows that the insulin infusion pump had the highest number of complaints, yet none of the recalled devices bore significant degree of text similarity to currently marketed devices. The mapping from the De Novo device case study was used to develop an ancestry map from the recalled predicate (recalled due to design flaws) to current substantially equivalent products in the market. Conclusions Besides enabling a better understanding of the risks and benefits of the 510(k) process, mapping of connectivity of various predicates could help increase consumer confidence in the medical devices that are currently in the marketplace.

scholarly journals PrediGen: A tool to track the genealogy of medical device predicates in the United States

2021 ◽  
Author(s):  
Dhruv Pai
Keyword(s):  
United States ◽  
Medical Device ◽  
Language Processing ◽  
Medical Devices ◽  
The United States ◽  
Risks And Benefits ◽  
Using Data ◽  
Device Manufacturer ◽  
The Right ◽  
Patients Perspective

In the United States, medical devices are regulated and subject to review by the Food and Drug Administration (“FDA”) before they can be marketed. Novel medical devices have to undergo a premarket authorization (PMA) process before they can proceed to market, and this process can be fairly cumbersome, expensive, and time-consuming. An alternate faster and less-pricey pathway to going to market is the 510(k) pathway. In this approach, if the device manufacturer can show that their device is substantially equivalent in safety and effectiveness to a pre-existing FDA-approved marketed device (or “predicates”), they can go to market with their device. Due to the possibility of daisy-chaining predicate devices, it can very quickly be difficult to unravel the logic and justification of how a particular medical device’s equivalence was established. From patients’ perspective, this minimizes transparency in the process. From a vendor perspective, it can be difficult to determine the right predicate that applies to their device. PrediGen (short for “Predicates Genealogy”) is being developed as an approach to graphically map the connectivity of various predicates in the medical device field using data publicly made available by the FDA, and by combining text mining and novel natural language processing (NLP) techniques. Besides enabling a better understanding of the risks and benefits of the 510(k) process, this tool can increase consumer confidence in the medical devices that are currently in the marketplace.

An American Language

2018 ◽  
Author(s):  
Rosina Lozano
Keyword(s):  
United States ◽  
National Policy ◽  
The United States ◽  
Spanish Language ◽  
Spanish Speakers ◽  
Language Recognition ◽  
Political Language ◽  
Political Issue ◽  
History Of ◽  
The U.S

An American Language is a political history of the Spanish language in the United States. The nation has always been multilingual and the Spanish language in particular has remained as an important political issue into the present. After the U.S.-Mexican War, the Spanish language became a language of politics as Spanish speakers in the U.S. Southwest used it to build territorial and state governments. In the twentieth century, Spanish became a political language where speakers and those opposed to its use clashed over what Spanish's presence in the United States meant. This book recovers this story by using evidence that includes Spanish language newspapers, letters, state and territorial session laws, and federal archives to profile the struggle and resilience of Spanish speakers who advocated for their language rights as U.S. citizens. Comparing Spanish as a language of politics and as a political language across the Southwest and noncontiguous territories provides an opportunity to measure shifts in allegiance to the nation and exposes differing forms of nationalism. Language concessions and continued use of Spanish is a measure of power. Official language recognition by federal or state officials validates Spanish speakers' claims to US citizenship. The long history of policies relating to language in the United States provides a way to measure how U.S. visions of itself have shifted due to continuous migration from Latin America. Spanish-speaking U.S. citizens are crucial arbiters of Spanish language politics and their successes have broader implications on national policy and our understanding of Americans.

Palestine Unbound

2018 ◽  
Vol 47 (3) ◽  
pp. 130-134
Keyword(s):  
United States ◽  
Human Rights ◽  
Task Force ◽  
The United States ◽  
Donald Trump ◽  
Tel Aviv ◽  
The Us ◽  
Intention To Move ◽  
Arab Israeli Conflict ◽  
The U.S

This section, updated regularly on the blog Palestine Square, covers popular conversations related to the Palestinians and the Arab-Israeli conflict during the quarter 16 November 2017 to 15 February 2018: #JerusalemIstheCapitalofPalestine went viral after U.S. president Donald Trump recognized Jerusalem as the capital of Israel and announced his intention to move the U.S. embassy there from Tel Aviv. The arrest of Palestinian teenager Ahed Tamimi for slapping an Israeli soldier also prompted a viral campaign under the hashtag #FreeAhed. A smaller campaign protested the exclusion of Palestinian human rights from the agenda of the annual Creating Change conference organized by the US-based National LGBTQ Task Force in Washington. And, UNRWA publicized its emergency funding appeal, following the decision of the United States to slash funding to the organization, with the hashtag #DignityIsPriceless.

The French Way

2011 ◽  
Author(s):  
Richard F. Kuisel
Keyword(s):  
United States ◽  
The United States ◽  
French Language ◽  
French Cinema ◽  
Free Markets ◽  
Technology Sector ◽  
Aids Epidemic ◽  
Political Reality ◽  
Politics And Culture ◽  
The U.S

There are over 1,000 McDonald's on French soil. Two Disney theme parks have opened near Paris in the last two decades. And American-inspired vocabulary such as “le weekend” has been absorbed into the French language. But as former French president Jacques Chirac put it: “The U.S. finds France unbearably pretentious. And we find the U.S. unbearably hegemonic.” Are the French fascinated or threatened by America? They Americanize yet are notorious for expressions of anti-Americanism. From McDonald's and Coca-Cola to free markets and foreign policy, this book looks closely at the conflicts and contradictions of France's relationship to American politics and culture. The book shows how the French have used America as both yardstick and foil to measure their own distinct national identity. France has charted its own path: it has welcomed America's products but rejected American policies; assailed Americ's “jungle capitalism” while liberalizing its own economy; attacked “Reaganomics” while defending French social security; and protected French cinema, television, food, and language even while ingesting American pop culture. The book examines France's role as an independent ally of the United States, but he also considers the country's failures in influencing the Reagan, Bush, and Clinton administrations. Whether investigating France's successful information technology sector or its spurning of American expertise during the AIDS epidemic, the book asks if this insistence on a French way represents a growing distance between Europe and the United States or a reaction to American globalization. Exploring cultural trends, values, public opinion, and political reality, this book delves into the complex relationship between two modern nations.

Latino Catholicism

2011 ◽  
Author(s):  
Timothy Matovina
Keyword(s):  
United States ◽  
Sixteenth Century ◽  
Catholic Church ◽  
Social Life ◽  
Social Issues ◽  
The United States ◽  
Societal Impact ◽  
Comprehensive Overview ◽  
Public Debates ◽  
The U.S

Most histories of Catholicism in the United States focus on the experience of Euro-American Catholics, whose views on social issues have dominated public debates. This book provides a comprehensive overview of the Latino Catholic experience in America from the sixteenth century to today, and offers the most in-depth examination to date of the important ways the U.S. Catholic Church, its evolving Latino majority, and American culture are mutually transforming one another. This book highlights the vital contributions of Latinos to American religious and social life, demonstrating in particular how their engagement with the U.S. cultural milieu is the most significant factor behind their ecclesial and societal impact.

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