Medical device design and regulation

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Bibliographic Details
Main Author: DeMarco, Carl T., (Author)
Format: eBook
Language: English
Published: Milwaukee, Wisconsin : ASQ Quality Press, 2011.
Subjects:
United States. > Food and Drug Administration.
United States > Food and Drug Administration
United States. > Food and Drug Administration
Medical instruments and apparatus > United States.
Medical instruments and apparatus > United States > Design and construction.
Medical instruments and apparatus > Safety regulations > United States.
Medical instruments and apparatus industry > United States.
Social control.
Public health.
Sociology.
Medical care.
Social sciences.
elektronické knihy
electronic books
ISBN: 9780873898164
0873898168
9781621980766
1621980766
6000049307
9786000049300
9780873891882
0873891880
Physical Description: 1 online resource (368 pages) : illustrations

Cover

Table of contents

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020 |a 0873898168  |q (e-book) 
020 |a 9781621980766  |q (electronic bk.) 
020 |a 1621980766  |q (electronic bk.) 
020 |a 6000049307 
020 |a 9786000049300 
020 |a 9780873891882  |q (electronic bk.) 
020 |a 0873891880  |q (electronic bk.) 
035 |a (OCoLC)893681506  |z (OCoLC)840765181  |z (OCoLC)961611523  |z (OCoLC)962662645  |z (OCoLC)990469108  |z (OCoLC)1055391721  |z (OCoLC)1065902198  |z (OCoLC)1081291935  |z (OCoLC)1162031723  |z (OCoLC)1228604410 
043 |a n-us--- 
100 1 |a DeMarco, Carl T.,  |e author. 
245 1 0 |a Medical device design and regulation /  |c Carl T. DeMarco. 
264 1 |a Milwaukee, Wisconsin :  |b ASQ Quality Press,  |c 2011. 
300 |a 1 online resource (368 pages) :  |b illustrations 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
504 |a Includes bibliographical references and index. 
505 0 |a Intro -- Title Page -- CIP data -- Dedication -- Table of Contents -- List of Figures and Tables -- List of Abbreviations -- Introduction -- Acknowledgments -- Chapter 1: Background and Regulatory Environment -- Part 1. Medical Device Design and Development -- Section 1. Major Steps in the Design and Development of a Medical Device -- Section 2. Teamwork in Industry and FDA -- Section 3. Medical Device Quality, Safety, and Effectiveness -- Part 2. The Medical Device Industry -- Section 1. Industry Demographics -- Section 2. Medical Device Innovations -- Section 3. The Regulated Industry -- Part 3. United States Food and Drug Administration -- Section 1. Organizational Structure -- Section 2. FDA Decision Making -- Section 3. CD RH Strategic Priorities and Transparency -- Section 4. Division of Small Manufacturers, International and Consumer Assistance -- Section 5. FDA Foreign Offices -- Part 4. The Legal Basis for Device Regulation -- Section 1. Interstate Commerce -- Section 2. The Federal Food, Drug, and Cosmetic Act (FDCA ) and Its Evolution -- Section 3. The Medical Device Amendments of 1976 -- Part 5. Quasi-Legal Requirements -- Section 1. Voluntary/Consensus Standards -- Section 2. FDA -Recognized Standards -- Section 3. Mandatory Standards -- Section 4. Guidance Documents -- Part 6. FDA Administrative Actions -- Section 1. FDA Regulations -- Section 2. Mandatory Standards -- Section 3. Administrative Hearings -- Part 7. Judicial Review -- Section 1. Agency Enforcement Actions -- Section 2. Challenging Agency Actions -- Part 8. State Regulation of Medical Devices -- Section 1. Model Uniform State Food, Drug, and Cosmetic Act -- Section 2. Preemption of State Laws and Regulations -- Part 9. International Aspects of Device Regulation -- Section 1. European Union Medical Device Regulation -- Section 2. Global Harmonization Task Force. 
505 8 |a Section 3. Other Requirements with International Implications -- Part 10. Confidentiality and Nonpublic Information -- Section 1. Nonpublic Information -- Section 2. Trade Secrets -- Section 3. Confidential Commercial Information -- Section 4. Financially Sensitive Information -- Section 5. Specific Patient Information -- Section 6. Specific Employee Information -- Section 7. Protecting Nonpublic Information -- Part 11. Monitoring and Auditing -- Section 1. Monitoring -- Section 2. Auditing -- Part 12. Patents -- Part 13. Medical Devices, Drugs, and Biologics -- Section 1. Medical Devices -- Section 2. Drug Products -- Section 3. Biological Products -- Section 4. Classification of Medical Devices -- Section 5. Classes of Medical Devices -- Section 6. Class I and Class II Device Exemptions -- Section 7. Restricted and Prescription Devices -- Section 8. Combination Products -- Section 9. Custom Devices -- Part 14. Exercises -- Chapter 2: Medical Device Design -- Part 1. Design Control Background -- Section 1. Overview of Design Control -- Section 2. Applicability of FDA's Design Regulation -- Section 3. International Design Control Standards -- Part 2. Design Planning and Record Keeping -- Section 1. Design Planning -- Section 2. Design History File -- Part 3. Design Inputs and Outputs -- Section 1. Design Inputs -- Section 2. Human Factors Engineering -- Section 3. Design Outputs -- Part 4. Design Verification and Design Validation -- Section 1. Verification -- Section 2. Validation -- Part 5. Design Review and Documentation -- Part 6. Design Transfer and Design Changes -- Section 1. Design Transfer -- Section 2. Design Changes -- Section 3. Documentation of Design Change -- Part 7. Design Failures -- Part 8. Exercises -- Chapter 3: Nonclinical Testing and GLPs -- Part 1. Nonclinical Testing -- Section 1. General Principles. 
505 8 |a Section 2. SO Ps and Protocols -- Section 3. Device Description -- Section 4. Performance Testing -- Section 5. Animal Experimentation and Evaluation -- Section 6. Biocompatibility -- Section 7. Sterility and Shelf Life -- Part 2. Good LaboratoryPractice -- Section 1. Scope and Applicability -- Section 2. The GLP Regulatory Scheme -- Section 3. Organization and Personnel -- Section 4. Facilities -- Section 5. Equipment -- Section 6. Testing Facilities Operations -- Section 7. Test and Control Articles -- Section 8. Protocols -- Section 9. Records and Reports -- Section 10. Disqualification of Testing Facilities -- Part 3. Exercises -- Chapter 4: Clinical Trials -- Good Clinical Practices -- Biostatistics -- Part 1. Background Information -- Section 1. Regulatory Scheme -- Section 2. International Guidelines for Medical Device Research -- Section 3. Major Clinical Trial Participants and Definitions -- Section 4. Ethics in Clinical Trials -- Section 5. Bias and Financial Conflicts of Interest -- Section 6. Monitoring and Auditing a Clinical Trial -- Section 7. Controls for Clinical Trials -- Part 2. Clinical Trial Design -- Section 1. The Investigational Plan -- Section 2. The Clinical Trial Protocol -- Section 3. Blinding -- Section 4. Study Controls -- Section 5. Number of Patients and Study Sites -- Section 6. Proving Safety and Effectiveness and Substantial Equivalence -- Part 3. Informed Consent -- Section 1. General Applicability -- Section 2. IR B and FDA Review and Approval of Informed Consent Form -- Section 3. Elements of Informed Consent -- Section 4. Documentation of Informed Consent -- Section 5. Emergency Use Exception from Informed Consent -- Section 6. Special Safeguards for Children -- Section 7. In Vitro Diagnostic Device (IVD) Testing -- Part 4. Institutional Review Boards -- Section 1. IRB Structure and Membership. 
505 8 |a Section 2. IRB Duties and Responsibilities -- Section 3. FDA Actions for Noncompliance by the IRB -- Part 5. Investigational Device Exemptions -- Section 1. Purpose of the IDE Regulation -- Section 2. The Role of Engineers and Other Scientistsin Clinical Studies -- Section 3. Applicability -- Section 4. Exempted Studies -- Section 5. Significant Risk Studies -- Section 6. Responsibilities of Sponsors -- Section 7. Responsibilities of Investigators -- Section 8. FDA Actions on IDE Applications -- Section 9. IDE Prohibitions -- Section 10. Treatment Use of an Investigational Device -- Section 11. Confidentiality of IDE Data -- Section 12. Nonsignificant Risk (NSR ) Studies -- Part 6. Bioresearch Monitoring -- Section 1. BIMO Inspections -- Section 2. Clinical Study Deficiencies -- Section 3. BIMO Enforcement Actions -- Part 7. Importing and Exporting Medical Devices for Investigational Use -- Section 1. Importing an Investigational Device -- Section 2. Exporting an Investigational Device -- Part 8. National Clinical Trials Data Bank -- Section 1. Background and Purpose -- Section 2. Exempted Clinical Trials -- Section 3. FDA Certification -- Part 9. Exercises -- Chapter 5: Marketing Applications -- The Scope of This Chapter -- Early Planning -- Part 1. Global Marketing Application Concepts -- Section 1. Overview of the Premarket Review Process -- Section 2. Valid Scientific Evidence -- Section 3. Labeling and Unapproved Uses -- Section 4. Advisory Committee Review and Outside Expertise -- Section 5. Intermediate FDA Actions During the Review Process -- Section 6. Financial Disclosure -- Section 7. Data Integrity -- Section 8. Bioresearch Monitoring -- Section 9. CDRH Electronic Copy Initiative -- Section 10. Medical Device User Fees -- Section 11. CDRH Premarket Review Submission Cover Sheet -- Part 2. Premarket Notification (510[k]). 
505 8 |a Section 1. Background -- Section 2. Applicability -- Section 3. Types of 510(k)s -- Section 4. The 510(k) and Substantial Equivalence -- Section 5. FDA Action on a 510(k) -- Section 6. Marketing a 510(k) Device -- Section 7. Custom Device Exemption -- Section 8. Request under Section 513(g) of the Act -- Section 9. Upcoming 510(k) Program Changes -- Part 3. PMAs/PDPs/HDEs -- Section 1. PMA Overview -- Section 2. Original PMA Submissions -- Section 3. Format and Content of a PMA Submission -- Section 4. The Determination of Safety and Effectiveness and the Summary of Safety and Effectiveness Data -- Section 5. PMA Meetings -- Section 6. FDA Actions -- Section 7. PMA Conditions of Approval Requirements -- Section 8. Post-Approval Reports -- Section 9. Adverse Reaction and Device Defect Reporting -- Section 10. Post-Approval Studies -- Section 11. PMA Supplements -- Section 12. Product Development Protocols -- Section 13. Humanitarian Device Exemptions -- Part 4. Importing and Exporting Medical Devices for Commercial Distribution -- Section 1. Importing a Medical Device -- Section 2. Exporting a Medical Device -- Part 5. Exercises -- Chapter 6: Post-Market Requirements -- Part 1. Medical Device Reporting -- Section 1. Applicability and Reportable Events -- Section 2. Reporting Responsibilities -- Section 3. Standard Operating Procedures for MDR -- Section 4. Record-Keeping Requirements -- Section 5. Exemptions, Variances, and Alternative Reporting Requirements -- Section 6. Public Disclosure of MDR Information -- Part 2. Post-market Surveillance Studies -- Section 1. Applicability and Scope -- Section 2. The PS Submission and PS Plan -- Section 3. FDA Actions -- Part 3. Medical Device Tracking -- Section 1. Applicability and Scope -- Section 2. Devices Subject to Tracking -- Section 3. The Tracking Process -- Section 4. Records and Reports. 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
590 |a Knovel  |b Knovel (All titles) 
610 1 0 |a United States.  |b Food and Drug Administration. 
610 1 2 |a United States  |b Food and Drug Administration 
610 1 7 |a United States.  |b Food and Drug Administration  |2 fast 
650 0 |a Medical instruments and apparatus  |z United States. 
650 0 |a Medical instruments and apparatus  |z United States  |x Design and construction. 
650 0 |a Medical instruments and apparatus  |x Safety regulations  |z United States. 
650 0 |a Medical instruments and apparatus industry  |z United States. 
650 0 |a Social control. 
650 0 |a Public health. 
650 0 |a Sociology. 
650 0 |a Medical care. 
650 0 |a Social sciences. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
776 0 8 |i Print version:  |a DeMarco, Carl T.  |t Medical device design and regulation.  |d Milwaukee, Wisconsin : ASQ Quality Press, 2011  |h xxxv, 328 pages ; 24 cm  |z 9780873898164  |w (DLC) 10929606 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpMDDR0001/medical-device-design?kpromoter=marc  |y Full text 

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