scholarly journals The Ball is in Your Court: Agenda for Research to Advance the Science of Patient Preferences in the Regulatory Review of Medical Devices in the United States

2017 ◽  
Vol 10 (5) ◽  
pp. 531-536 ◽  
Author(s):  
Bennett Levitan ◽  
A. Brett Hauber ◽  
Marina G. Damiano ◽  
Ross Jaffe ◽  
Stephanie Christopher
Keyword(s):  
United States ◽  
Medical Devices ◽  
Patient Preferences ◽  
The United States ◽  
Regulatory Review

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.

Rationales of delay and difference in regulatory review by Japan, the United States, and Europe among new drugs first approved in Japan

2021 ◽  
Author(s):  
Mototsugu Tanaka ◽  
Mayumi Idei ◽  
Hiroshi Sakaguchi ◽  
Ryosuke Kato ◽  
Daisuke Sato ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
New Drugs ◽  
Regulatory Review

Patient preferences for interferon alfa in multiple myeloma.

1997 ◽  
Vol 15 (4) ◽  
pp. 1672-1679 ◽  
Author(s):  
H Ludwig ◽  
E Fritz ◽  
J Neuda ◽  
B G Durie
Keyword(s):  
United States ◽  
Multiple Myeloma ◽  
Overall Survival ◽  
Patient Preferences ◽  
Maintenance Treatment ◽  
The United States ◽  
Interferon Alfa ◽  
Medical Decision ◽  
Published Data ◽  
Financial Cost

PURPOSE Interferon alfa treatment in multiple myeloma marginally improves relapse-free and overall survival. Often it does so at the expense of toxicity and financial cost. If patients are unwilling or unable to participate in the decision of whether to initiate such treatment, known patient preferences can serve as guidelines for the physician. We interviewed myeloma patients in the United States to obtain information that might facilitate medical decision-making. PATIENTS AND METHODS Three hundred fifty-five myeloma patients throughout the United States were interviewed by telephone. Without identifying interferon alfa as the treatment agent, interviewers described potential adverse effects, financial cost, and self-injection procedures. The potential benefits of four treatment choices, derived from a meta-analysis of published data, were presented as gains in remission rate (+10%), remission duration (an additional 4 and 7 months, respectively, for induction and maintenance treatment), and overall survival (an additional 3 and 6 months, respectively, for induction and maintenance treatment). Patients' choices for or against use of the unidentified substance were recorded, and interferon was subsequently disclosed as the treatment. The profiles of patients making different choices were determined using multivariate regression techniques. RESULTS Approximately half of the patients accepted the unidentified treatment if remission and/or survival improved by at least 6 months. Accepters were younger and more likely to have used interferon. Of patients who rejected the unidentified treatment, 25% to 50% would have been willing to accept it if the benefits were > or = 12 months. Test/retest reliability of all choices, determined in 36 cancer patients, was 0.896. CONCLUSION In multiple myeloma, interferon therapy and, by inference, other treatments with comparable features are acceptable to approximately half of the patients if a 6-month gain in relapse-free or overall survival can be expected.

scholarly journals Patient Preferences for Endometriosis Pain Treatments in the United States

2019 ◽  
Vol 22 (6) ◽  
pp. 728-738 ◽  
Author(s):  
Christine Poulos ◽  
Ahmed M. Soliman ◽  
Cheryl L. Renz ◽  
Joshua Posner ◽  
Sanjay K. Agarwal
Keyword(s):  
United States ◽  
Patient Preferences ◽  
The United States

Regulation of Medical Devices in the United States and European Union

2012 ◽  
Vol 366 (9) ◽  
pp. 848-855 ◽  
Author(s):  
Daniel B. Kramer ◽  
Shuai Xu ◽  
Aaron S. Kesselheim
Keyword(s):  
United States ◽  
European Union ◽  
Medical Devices ◽  
The United States

Antibacterial activity studies of plasma polymerised cineole films

2014 ◽  
Vol 2 (31) ◽  
pp. 4993-5002 ◽  
Author(s):  
Adoracion Pegalajar-Jurado ◽  
Christopher D. Easton ◽  
Katie E. Styan ◽  
Sally L. McArthur
Keyword(s):  
United States ◽  
Antibacterial Activity ◽  
Medical Devices ◽  
Bacterial Infections ◽  
The United States ◽  
Patient Treatment

Costs associated with bacterial infections in medical devices exceed $US 30 billion each year in the United States alone due to device revisions and patient treatment.

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