Clinical Evaluation of Medical Devices: Principles and Case StudiesKaren M. Becker, John J. Whyte The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs. |
From inside the book
Results 1-5 of 42
Page v
... Food and Drug Administration status of each drug or device used in their clinical practice. The publisher, editors, and authors are not responsible for errors or omissions or for any consequences from the application of the information ...
... Food and Drug Administration status of each drug or device used in their clinical practice. The publisher, editors, and authors are not responsible for errors or omissions or for any consequences from the application of the information ...
Page ix
... , Chief, General and Surgical Devices Branch, Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration (FDA), Rockville, MD PETER M. KAZON, ESQ., Senior Counsel, Alston & Bird LLP, ix Contributors.
... , Chief, General and Surgical Devices Branch, Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration (FDA), Rockville, MD PETER M. KAZON, ESQ., Senior Counsel, Alston & Bird LLP, ix Contributors.
Page x
... Food, Drug, and Cosmetic Law, Kirkpatrick & Lockhart, LLP, Washington, DC MICHAEL PARIDES, PhD, Associate Professor of Biostatistics, Department of Biostatistics and International Center for Health Outcomes and Innovation Research ...
... Food, Drug, and Cosmetic Law, Kirkpatrick & Lockhart, LLP, Washington, DC MICHAEL PARIDES, PhD, Associate Professor of Biostatistics, Department of Biostatistics and International Center for Health Outcomes and Innovation Research ...
Page 3
... Food, Drug, and Cosmetic (FD&C) Act, the term medical device: ...means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article...intended for use in the diagnosis of ...
... Food, Drug, and Cosmetic (FD&C) Act, the term medical device: ...means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article...intended for use in the diagnosis of ...
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... Food and Drug Administration (FDA) is concerned with the safety and efficacy of a product, whereas health care providers and payors are interested in comparative performance, superiority or product differentiation claims, and/or ...
... Food and Drug Administration (FDA) is concerned with the safety and efficacy of a product, whereas health care providers and payors are interested in comparative performance, superiority or product differentiation claims, and/or ...
Contents
21 | |
Requirements for Medicare Coverage | 59 |
Postmarket Requirements for Significant Risk Devices 81 Suzan Onel | 99 |
Intellectual Property Protection for Medical Devices | 117 |
HIPAA Compliance in Clinical Research 141 Peter M Kazon and Sharon D Brooks | 153 |
Developing DrugDevice Combination Products | 161 |
Wall Streets Perspective on Medical Device | 187 |
Left Ventricular Assist Device | 199 |
A Randomized ShamProcedure | 217 |
Use of Multiple Imputation Models | 251 |
Case Studies on the Local Coverage Process 253 Mitchell I Burken | 269 |
Role of Device Retrieval and Analysis | 305 |
Other editions - View all
Clinical Evaluation of Medical Devices: Principles and Case Studies Karen M. Becker,John J. Whyte No preview available - 2007 |
Clinical Evaluation of Medical Devices: Principles and Case Studies Karen M. Becker,John J. Whyte No preview available - 2010 |
Clinical Evaluation of Medical Devices: Principles and Case Studies Karen M. Becker,John J. Whyte No preview available - 2005 |
Common terms and phrases
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