Managing medical devices within a regulatory framework
3.6.1 CLINICAL EVALUATION AND IDE SUBMISSION3.7 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 4 -- Manufacturing/Distribution Considerations; 4.1 INTRODUCTION; 4.2 US PRECLINICAL STAGE; 4.2.1 PRODUCT LIFE CYCLE MANAGEMENT; 4.2.2 CURRENT GOOD MANUFACTURING PRACTICES; 4.3 U...
Ausführliche Beschreibung
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| Autor*in: |
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| Format: |
E-Book |
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| Sprache: |
Englisch |
| Erschienen: |
Amsterdam: Elsevier ; 2016, ©2017 |
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| Schlagwörter: |
Medical instruments and apparatus, Management MEDICAL ; Alternative Medicine |
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| Formangabe: |
Electronic books |
| Anmerkung: |
Print version record |
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| Umfang: |
Online Ressource (382) |
| Reproduktion: |
Online-Ausg. |
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| Links: | |
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| ISBN: |
978-0-12-804192-5 0-12-804192-7 |
| Katalog-ID: |
1655295365 |
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| 245 | 1 | 0 | |a Managing medical devices within a regulatory framework |c edited by Beth Ann Fielder |
| 264 | 1 | |a Amsterdam |b Elsevier |c 2016, ©2017 | |
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| 520 | |a 3.6.1 CLINICAL EVALUATION AND IDE SUBMISSION3.7 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 4 -- Manufacturing/Distribution Considerations; 4.1 INTRODUCTION; 4.2 US PRECLINICAL STAGE; 4.2.1 PRODUCT LIFE CYCLE MANAGEMENT; 4.2.2 CURRENT GOOD MANUFACTURING PRACTICES; 4.3 US POSTMARKET STAGE; 4.3.1 ADVERSE EVENT MEDICAL DEVICE REPORTING; 4.3.2 POSTMARKETING 522 STUDIES; 4.3.3 REIMBURSEMENT; 4.4 EUROPEAN UNION CE MARKING: PREMARKETING STAGE; 4.4.1 CE MARKING; 4.4.2 NOTIFIED BODY BEST PRACTICES; 4.5 EU POSTMARKET STAGE; 4.5.1 ADVERSE EVENT MEDICAL DEVICE REPORTING | ||
| 520 | |a 4.5.2 POSTMARKETING STUDIES4.5.3 REIMBURSEMENT; 4.6 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 2 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5.1 INTRODUCTION; 5.2 BIOCOMPATIBILITY; 5.2.1 ISO AND OTHER RESOURCE GUIDANCE; 5.2.2 CROSS-FUNCTIONAL KNOWLEDGE BASE REPOSITORIES; 5.2.2.1 The Front End of Medical Device Development in the Product Life Cycle; 5.2.2.2 The Back End of Medical Device Development in the Product Life Cycle | ||
| 520 | |a Front Cover; Managing Medical Devices within a Regulatory Framework; Related titles; Managing Medical Devices within a Regulatory Framework; Copyright; Dedication; Contents; List of Contributors; Foreword; Preface; 1 -- Medical Device Development and Regulatory Overview; 1 -- Reframing Product Life Cycle for Medical Devices; 1.1 INTRODUCTION; 1.2 FDA TOTAL PRODUCT LIFE CYCLE; 1.2.1 CONCEPTION; 1.2.2 PROTOTYPE; 1.2.3 PRECLINICAL INVESTIGATION; 1.2.4 ADVANCED CLINICAL/POSTMARKETING STUDIES; 1.2.5 END OF LIFE; 1.3 EUROPEAN COMMISSION PRODUCT LIFE CYCLE; 1.4 SUMMARY; DEFINITIONS; REFERENCES | ||
| 520 | |a RECOMMENDATIONS FOR ADDITIONAL READING2 -- Overview of Medical Device Clinical Trials; 2.1 INTRODUCTION; 2.2 MEDICAL DEVICE SUBMISSIONS OVERVIEW; 2.3 MEDICAL DEVICE CLINICAL TRIALS; 2.3.1 INVESTIGATIONAL DEVICE EXEMPTION; 2.3.2 CLINICAL TRIALS; 2.3.3 MANUFACTURING AND ADDITIONAL STANDARDS; 2.4 REGULATORY PROFILE OF THE US MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.4.1 CLASS I MEDICAL DEVICES; 2.4.2 CLASS II MEDICAL DEVICES; 2.4.3 CLASS III MEDICAL DEVICES; 2.5 REGULATORY PROFILE OF THE EU MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.6 SUMMARY; DEFINITIONS; REFERENCES | ||
| 520 | |a RECOMMENDATIONS FOR ADDITIONAL READING3 -- Review Regulatory Guidelines by Device Classification Type; 3.1 INTRODUCTION; 3.2 BASIC OVERVIEW OF THE PREMARKET NOTIFICATION 510(K); 3.2.1 TYPES OF 510(K); 3.2.2 PRIMARY 510(K) SUBMISSION STEPS; 3.2.3 SUBSTANTIAL EQUIVALENCE; 3.3 PREMARKET APPROVAL APPLICATION REGULATORY PATH; 3.3.1 PMA TYPES; 3.3.2 PRESUBMISSION INTERACTION; 3.3.3 PMA FOOD AND DRUG ADMINISTRATION REVIEWS; 3.3.4 PRE-INVESTIGATIONAL DEVICE EXEMPTION SUBMISSION; 3.4 Medical Device Class I; 3.5 MEDICAL DEVICE CLASS II; 3.6 MEDICAL DEVICE CLASS III | ||
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Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. Testzugang ZHB Lübeck z 26-02-22 132 01 0959 4499994888 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. Zeitlich begrenzte Lizenzierung k 13-03-24 185 01 3519 4514730211 OLR-EBS Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 23-04-24 370 01 4370 4540277103 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. i z 20-06-24 2020 01 DE-Ch1 4520359996 00 --%%-- --%%-- n n Campuslizenz l01 03-05-24 2111 02 DE-944 4046053003 00 --%%-- E-Book Elsevier --%%-- n Elektronischer Volltext - Campuslizenz l01 27-01-22 105 01 0841 http://www.sciencedirect.com/science/book/9780128041796 132 01 0959 Zugriff nur für Angehörige der Hochschule Osnabrück im Hochschulnetz https://www.sciencedirect.com/science/book/9780128041796 185 01 3519 http://www.sciencedirect.com/science/book/9780128041796 370 01 4370 E-Book: Zugriff im HCU-Netz. Zugriff von außerhalb nur für HCU-Angehörige möglich https://www.sciencedirect.com/science/book/9780128041796 2020 01 DE-Ch1 https://www.sciencedirect.com/science/book/9780128041796 2111 02 DE-944 https://www.sciencedirect.com/science/book/9780128041796 132 01 0959 00 EBooks Elsevier Engineering 105 01 0841 OLR-ELV-TEST 132 01 0959 EBS Elsevier 185 01 3519 OLR-EBS 370 01 4370 EBS Elsevier |
| spelling |
9780128041925 978-0-12-804192-5 0128041927 0-12-804192-7 9780128041796 012804179X (DE-627)1655295365 (DE-576)517985462 (DE-599)BSZ517985462 (OCoLC)958455787 (EBP)003090450 (ELSEVIER)ocn958455787 DE-627 ger DE-627 rakwb eng XA-NL R856 HEA012000 bisacsh HEA020000 bisacsh MED004000 bisacsh MED101000 bisacsh MED109000 bisacsh MED029000 bisacsh MED040000 bisacsh MED092000 bisacsh HEA 012000 bisacsh MED 004000 bisacsh HEA 020000 bisacsh MED 101000 bisacsh MED 029000 bisacsh MED 092000 bisacsh MED 040000 bisacsh MED 109000 bisacsh HEA 012000 bisacsh MED 092000 bisacsh MED 004000 bisacsh MED 109000 bisacsh MED 101000 bisacsh MED 040000 bisacsh HEA 020000 bisacsh MED 029000 bisacsh Managing medical devices within a regulatory framework edited by Beth Ann Fielder Amsterdam Elsevier 2016, ©2017 Online Ressource (382) nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Print version record 3.6.1 CLINICAL EVALUATION AND IDE SUBMISSION3.7 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 4 -- Manufacturing/Distribution Considerations; 4.1 INTRODUCTION; 4.2 US PRECLINICAL STAGE; 4.2.1 PRODUCT LIFE CYCLE MANAGEMENT; 4.2.2 CURRENT GOOD MANUFACTURING PRACTICES; 4.3 US POSTMARKET STAGE; 4.3.1 ADVERSE EVENT MEDICAL DEVICE REPORTING; 4.3.2 POSTMARKETING 522 STUDIES; 4.3.3 REIMBURSEMENT; 4.4 EUROPEAN UNION CE MARKING: PREMARKETING STAGE; 4.4.1 CE MARKING; 4.4.2 NOTIFIED BODY BEST PRACTICES; 4.5 EU POSTMARKET STAGE; 4.5.1 ADVERSE EVENT MEDICAL DEVICE REPORTING 4.5.2 POSTMARKETING STUDIES4.5.3 REIMBURSEMENT; 4.6 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 2 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5.1 INTRODUCTION; 5.2 BIOCOMPATIBILITY; 5.2.1 ISO AND OTHER RESOURCE GUIDANCE; 5.2.2 CROSS-FUNCTIONAL KNOWLEDGE BASE REPOSITORIES; 5.2.2.1 The Front End of Medical Device Development in the Product Life Cycle; 5.2.2.2 The Back End of Medical Device Development in the Product Life Cycle Front Cover; Managing Medical Devices within a Regulatory Framework; Related titles; Managing Medical Devices within a Regulatory Framework; Copyright; Dedication; Contents; List of Contributors; Foreword; Preface; 1 -- Medical Device Development and Regulatory Overview; 1 -- Reframing Product Life Cycle for Medical Devices; 1.1 INTRODUCTION; 1.2 FDA TOTAL PRODUCT LIFE CYCLE; 1.2.1 CONCEPTION; 1.2.2 PROTOTYPE; 1.2.3 PRECLINICAL INVESTIGATION; 1.2.4 ADVANCED CLINICAL/POSTMARKETING STUDIES; 1.2.5 END OF LIFE; 1.3 EUROPEAN COMMISSION PRODUCT LIFE CYCLE; 1.4 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING2 -- Overview of Medical Device Clinical Trials; 2.1 INTRODUCTION; 2.2 MEDICAL DEVICE SUBMISSIONS OVERVIEW; 2.3 MEDICAL DEVICE CLINICAL TRIALS; 2.3.1 INVESTIGATIONAL DEVICE EXEMPTION; 2.3.2 CLINICAL TRIALS; 2.3.3 MANUFACTURING AND ADDITIONAL STANDARDS; 2.4 REGULATORY PROFILE OF THE US MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.4.1 CLASS I MEDICAL DEVICES; 2.4.2 CLASS II MEDICAL DEVICES; 2.4.3 CLASS III MEDICAL DEVICES; 2.5 REGULATORY PROFILE OF THE EU MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.6 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING3 -- Review Regulatory Guidelines by Device Classification Type; 3.1 INTRODUCTION; 3.2 BASIC OVERVIEW OF THE PREMARKET NOTIFICATION 510(K); 3.2.1 TYPES OF 510(K); 3.2.2 PRIMARY 510(K) SUBMISSION STEPS; 3.2.3 SUBSTANTIAL EQUIVALENCE; 3.3 PREMARKET APPROVAL APPLICATION REGULATORY PATH; 3.3.1 PMA TYPES; 3.3.2 PRESUBMISSION INTERACTION; 3.3.3 PMA FOOD AND DRUG ADMINISTRATION REVIEWS; 3.3.4 PRE-INVESTIGATIONAL DEVICE EXEMPTION SUBMISSION; 3.4 Medical Device Class I; 3.5 MEDICAL DEVICE CLASS II; 3.6 MEDICAL DEVICE CLASS III Online-Ausg. Medical instruments and apparatus Management Medical instruments and apparatus Management HEALTH & FITNESS ; Holism HEALTH & FITNESS ; Reference MEDICAL ; Alternative Medicine MEDICAL ; Atlases MEDICAL ; Essays MEDICAL ; Family & General Practice MEDICAL ; Holistic Medicine MEDICAL ; Osteopathy Médecine - Appareils et instruments - Gestion (CaQQLa)201-0015728 Electronic books Electronic books Fiedler, Beth Ann oth 012804179X Erscheint auch als Druck-Ausgabe Managing medical devices within a regulatory framework Amsterdam : Elsevier, 2016, ©2017 https://www.sciencedirect.com/science/book/9780128041796 X:ELSEVIER Verlag lizenzpflichtig http://www.sciencedirect.com/science/book/9780128041796 X:ELSEVIER Verlag Volltext (DE-627)879400137 BSZ-33-EBS-HSAA GBV-33-EBS-MRI GBV-33-EBS-ZHB GBV-33-Freedom-BL ZDB-33-EGE 2016 ZDB-33-EBS ZDB-33-ESD GBV-33-EBS-HST BSZ-33-EBS-C1UB GBV_ILN_105 ISIL_DE-841 SYSFLAG_1 GBV_KXP GBV_ILN_132 ISIL_DE-959 GBV_ILN_185 ISIL_DE-Sra5 GBV_ILN_370 ISIL_DE-1373 GBV_ILN_2020 ISIL_DE-Ch1 GBV_ILN_2111 ISIL_DE-944 GBV ExPruef BO 045F 610.284 045F 610.28/4 105 01 0841 4074406578 OLR-ELV-TEST Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. Testzugang ZHB Lübeck z 26-02-22 132 01 0959 4499994888 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. Zeitlich begrenzte Lizenzierung k 13-03-24 185 01 3519 4514730211 OLR-EBS Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 23-04-24 370 01 4370 4540277103 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. i z 20-06-24 2020 01 DE-Ch1 4520359996 00 --%%-- --%%-- n n Campuslizenz l01 03-05-24 2111 02 DE-944 4046053003 00 --%%-- E-Book Elsevier --%%-- n Elektronischer Volltext - Campuslizenz l01 27-01-22 105 01 0841 http://www.sciencedirect.com/science/book/9780128041796 132 01 0959 Zugriff nur für Angehörige der Hochschule Osnabrück im Hochschulnetz https://www.sciencedirect.com/science/book/9780128041796 185 01 3519 http://www.sciencedirect.com/science/book/9780128041796 370 01 4370 E-Book: Zugriff im HCU-Netz. Zugriff von außerhalb nur für HCU-Angehörige möglich https://www.sciencedirect.com/science/book/9780128041796 2020 01 DE-Ch1 https://www.sciencedirect.com/science/book/9780128041796 2111 02 DE-944 https://www.sciencedirect.com/science/book/9780128041796 132 01 0959 00 EBooks Elsevier Engineering 105 01 0841 OLR-ELV-TEST 132 01 0959 EBS Elsevier 185 01 3519 OLR-EBS 370 01 4370 EBS Elsevier |
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9780128041925 978-0-12-804192-5 0128041927 0-12-804192-7 9780128041796 012804179X (DE-627)1655295365 (DE-576)517985462 (DE-599)BSZ517985462 (OCoLC)958455787 (EBP)003090450 (ELSEVIER)ocn958455787 DE-627 ger DE-627 rakwb eng XA-NL R856 HEA012000 bisacsh HEA020000 bisacsh MED004000 bisacsh MED101000 bisacsh MED109000 bisacsh MED029000 bisacsh MED040000 bisacsh MED092000 bisacsh HEA 012000 bisacsh MED 004000 bisacsh HEA 020000 bisacsh MED 101000 bisacsh MED 029000 bisacsh MED 092000 bisacsh MED 040000 bisacsh MED 109000 bisacsh HEA 012000 bisacsh MED 092000 bisacsh MED 004000 bisacsh MED 109000 bisacsh MED 101000 bisacsh MED 040000 bisacsh HEA 020000 bisacsh MED 029000 bisacsh Managing medical devices within a regulatory framework edited by Beth Ann Fielder Amsterdam Elsevier 2016, ©2017 Online Ressource (382) nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Print version record 3.6.1 CLINICAL EVALUATION AND IDE SUBMISSION3.7 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 4 -- Manufacturing/Distribution Considerations; 4.1 INTRODUCTION; 4.2 US PRECLINICAL STAGE; 4.2.1 PRODUCT LIFE CYCLE MANAGEMENT; 4.2.2 CURRENT GOOD MANUFACTURING PRACTICES; 4.3 US POSTMARKET STAGE; 4.3.1 ADVERSE EVENT MEDICAL DEVICE REPORTING; 4.3.2 POSTMARKETING 522 STUDIES; 4.3.3 REIMBURSEMENT; 4.4 EUROPEAN UNION CE MARKING: PREMARKETING STAGE; 4.4.1 CE MARKING; 4.4.2 NOTIFIED BODY BEST PRACTICES; 4.5 EU POSTMARKET STAGE; 4.5.1 ADVERSE EVENT MEDICAL DEVICE REPORTING 4.5.2 POSTMARKETING STUDIES4.5.3 REIMBURSEMENT; 4.6 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 2 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5.1 INTRODUCTION; 5.2 BIOCOMPATIBILITY; 5.2.1 ISO AND OTHER RESOURCE GUIDANCE; 5.2.2 CROSS-FUNCTIONAL KNOWLEDGE BASE REPOSITORIES; 5.2.2.1 The Front End of Medical Device Development in the Product Life Cycle; 5.2.2.2 The Back End of Medical Device Development in the Product Life Cycle Front Cover; Managing Medical Devices within a Regulatory Framework; Related titles; Managing Medical Devices within a Regulatory Framework; Copyright; Dedication; Contents; List of Contributors; Foreword; Preface; 1 -- Medical Device Development and Regulatory Overview; 1 -- Reframing Product Life Cycle for Medical Devices; 1.1 INTRODUCTION; 1.2 FDA TOTAL PRODUCT LIFE CYCLE; 1.2.1 CONCEPTION; 1.2.2 PROTOTYPE; 1.2.3 PRECLINICAL INVESTIGATION; 1.2.4 ADVANCED CLINICAL/POSTMARKETING STUDIES; 1.2.5 END OF LIFE; 1.3 EUROPEAN COMMISSION PRODUCT LIFE CYCLE; 1.4 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING2 -- Overview of Medical Device Clinical Trials; 2.1 INTRODUCTION; 2.2 MEDICAL DEVICE SUBMISSIONS OVERVIEW; 2.3 MEDICAL DEVICE CLINICAL TRIALS; 2.3.1 INVESTIGATIONAL DEVICE EXEMPTION; 2.3.2 CLINICAL TRIALS; 2.3.3 MANUFACTURING AND ADDITIONAL STANDARDS; 2.4 REGULATORY PROFILE OF THE US MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.4.1 CLASS I MEDICAL DEVICES; 2.4.2 CLASS II MEDICAL DEVICES; 2.4.3 CLASS III MEDICAL DEVICES; 2.5 REGULATORY PROFILE OF THE EU MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.6 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING3 -- Review Regulatory Guidelines by Device Classification Type; 3.1 INTRODUCTION; 3.2 BASIC OVERVIEW OF THE PREMARKET NOTIFICATION 510(K); 3.2.1 TYPES OF 510(K); 3.2.2 PRIMARY 510(K) SUBMISSION STEPS; 3.2.3 SUBSTANTIAL EQUIVALENCE; 3.3 PREMARKET APPROVAL APPLICATION REGULATORY PATH; 3.3.1 PMA TYPES; 3.3.2 PRESUBMISSION INTERACTION; 3.3.3 PMA FOOD AND DRUG ADMINISTRATION REVIEWS; 3.3.4 PRE-INVESTIGATIONAL DEVICE EXEMPTION SUBMISSION; 3.4 Medical Device Class I; 3.5 MEDICAL DEVICE CLASS II; 3.6 MEDICAL DEVICE CLASS III Online-Ausg. Medical instruments and apparatus Management Medical instruments and apparatus Management HEALTH & FITNESS ; Holism HEALTH & FITNESS ; Reference MEDICAL ; Alternative Medicine MEDICAL ; Atlases MEDICAL ; Essays MEDICAL ; Family & General Practice MEDICAL ; Holistic Medicine MEDICAL ; Osteopathy Médecine - Appareils et instruments - Gestion (CaQQLa)201-0015728 Electronic books Electronic books Fiedler, Beth Ann oth 012804179X Erscheint auch als Druck-Ausgabe Managing medical devices within a regulatory framework Amsterdam : Elsevier, 2016, ©2017 https://www.sciencedirect.com/science/book/9780128041796 X:ELSEVIER Verlag lizenzpflichtig http://www.sciencedirect.com/science/book/9780128041796 X:ELSEVIER Verlag Volltext (DE-627)879400137 BSZ-33-EBS-HSAA GBV-33-EBS-MRI GBV-33-EBS-ZHB GBV-33-Freedom-BL ZDB-33-EGE 2016 ZDB-33-EBS ZDB-33-ESD GBV-33-EBS-HST BSZ-33-EBS-C1UB GBV_ILN_105 ISIL_DE-841 SYSFLAG_1 GBV_KXP GBV_ILN_132 ISIL_DE-959 GBV_ILN_185 ISIL_DE-Sra5 GBV_ILN_370 ISIL_DE-1373 GBV_ILN_2020 ISIL_DE-Ch1 GBV_ILN_2111 ISIL_DE-944 GBV ExPruef BO 045F 610.284 045F 610.28/4 105 01 0841 4074406578 OLR-ELV-TEST Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. Testzugang ZHB Lübeck z 26-02-22 132 01 0959 4499994888 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. Zeitlich begrenzte Lizenzierung k 13-03-24 185 01 3519 4514730211 OLR-EBS Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 23-04-24 370 01 4370 4540277103 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. i z 20-06-24 2020 01 DE-Ch1 4520359996 00 --%%-- --%%-- n n Campuslizenz l01 03-05-24 2111 02 DE-944 4046053003 00 --%%-- E-Book Elsevier --%%-- n Elektronischer Volltext - Campuslizenz l01 27-01-22 105 01 0841 http://www.sciencedirect.com/science/book/9780128041796 132 01 0959 Zugriff nur für Angehörige der Hochschule Osnabrück im Hochschulnetz https://www.sciencedirect.com/science/book/9780128041796 185 01 3519 http://www.sciencedirect.com/science/book/9780128041796 370 01 4370 E-Book: Zugriff im HCU-Netz. Zugriff von außerhalb nur für HCU-Angehörige möglich https://www.sciencedirect.com/science/book/9780128041796 2020 01 DE-Ch1 https://www.sciencedirect.com/science/book/9780128041796 2111 02 DE-944 https://www.sciencedirect.com/science/book/9780128041796 132 01 0959 00 EBooks Elsevier Engineering 105 01 0841 OLR-ELV-TEST 132 01 0959 EBS Elsevier 185 01 3519 OLR-EBS 370 01 4370 EBS Elsevier |
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9780128041925 978-0-12-804192-5 0128041927 0-12-804192-7 9780128041796 012804179X (DE-627)1655295365 (DE-576)517985462 (DE-599)BSZ517985462 (OCoLC)958455787 (EBP)003090450 (ELSEVIER)ocn958455787 DE-627 ger DE-627 rakwb eng XA-NL R856 HEA012000 bisacsh HEA020000 bisacsh MED004000 bisacsh MED101000 bisacsh MED109000 bisacsh MED029000 bisacsh MED040000 bisacsh MED092000 bisacsh HEA 012000 bisacsh MED 004000 bisacsh HEA 020000 bisacsh MED 101000 bisacsh MED 029000 bisacsh MED 092000 bisacsh MED 040000 bisacsh MED 109000 bisacsh HEA 012000 bisacsh MED 092000 bisacsh MED 004000 bisacsh MED 109000 bisacsh MED 101000 bisacsh MED 040000 bisacsh HEA 020000 bisacsh MED 029000 bisacsh Managing medical devices within a regulatory framework edited by Beth Ann Fielder Amsterdam Elsevier 2016, ©2017 Online Ressource (382) nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Print version record 3.6.1 CLINICAL EVALUATION AND IDE SUBMISSION3.7 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 4 -- Manufacturing/Distribution Considerations; 4.1 INTRODUCTION; 4.2 US PRECLINICAL STAGE; 4.2.1 PRODUCT LIFE CYCLE MANAGEMENT; 4.2.2 CURRENT GOOD MANUFACTURING PRACTICES; 4.3 US POSTMARKET STAGE; 4.3.1 ADVERSE EVENT MEDICAL DEVICE REPORTING; 4.3.2 POSTMARKETING 522 STUDIES; 4.3.3 REIMBURSEMENT; 4.4 EUROPEAN UNION CE MARKING: PREMARKETING STAGE; 4.4.1 CE MARKING; 4.4.2 NOTIFIED BODY BEST PRACTICES; 4.5 EU POSTMARKET STAGE; 4.5.1 ADVERSE EVENT MEDICAL DEVICE REPORTING 4.5.2 POSTMARKETING STUDIES4.5.3 REIMBURSEMENT; 4.6 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 2 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5.1 INTRODUCTION; 5.2 BIOCOMPATIBILITY; 5.2.1 ISO AND OTHER RESOURCE GUIDANCE; 5.2.2 CROSS-FUNCTIONAL KNOWLEDGE BASE REPOSITORIES; 5.2.2.1 The Front End of Medical Device Development in the Product Life Cycle; 5.2.2.2 The Back End of Medical Device Development in the Product Life Cycle Front Cover; Managing Medical Devices within a Regulatory Framework; Related titles; Managing Medical Devices within a Regulatory Framework; Copyright; Dedication; Contents; List of Contributors; Foreword; Preface; 1 -- Medical Device Development and Regulatory Overview; 1 -- Reframing Product Life Cycle for Medical Devices; 1.1 INTRODUCTION; 1.2 FDA TOTAL PRODUCT LIFE CYCLE; 1.2.1 CONCEPTION; 1.2.2 PROTOTYPE; 1.2.3 PRECLINICAL INVESTIGATION; 1.2.4 ADVANCED CLINICAL/POSTMARKETING STUDIES; 1.2.5 END OF LIFE; 1.3 EUROPEAN COMMISSION PRODUCT LIFE CYCLE; 1.4 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING2 -- Overview of Medical Device Clinical Trials; 2.1 INTRODUCTION; 2.2 MEDICAL DEVICE SUBMISSIONS OVERVIEW; 2.3 MEDICAL DEVICE CLINICAL TRIALS; 2.3.1 INVESTIGATIONAL DEVICE EXEMPTION; 2.3.2 CLINICAL TRIALS; 2.3.3 MANUFACTURING AND ADDITIONAL STANDARDS; 2.4 REGULATORY PROFILE OF THE US MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.4.1 CLASS I MEDICAL DEVICES; 2.4.2 CLASS II MEDICAL DEVICES; 2.4.3 CLASS III MEDICAL DEVICES; 2.5 REGULATORY PROFILE OF THE EU MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.6 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING3 -- Review Regulatory Guidelines by Device Classification Type; 3.1 INTRODUCTION; 3.2 BASIC OVERVIEW OF THE PREMARKET NOTIFICATION 510(K); 3.2.1 TYPES OF 510(K); 3.2.2 PRIMARY 510(K) SUBMISSION STEPS; 3.2.3 SUBSTANTIAL EQUIVALENCE; 3.3 PREMARKET APPROVAL APPLICATION REGULATORY PATH; 3.3.1 PMA TYPES; 3.3.2 PRESUBMISSION INTERACTION; 3.3.3 PMA FOOD AND DRUG ADMINISTRATION REVIEWS; 3.3.4 PRE-INVESTIGATIONAL DEVICE EXEMPTION SUBMISSION; 3.4 Medical Device Class I; 3.5 MEDICAL DEVICE CLASS II; 3.6 MEDICAL DEVICE CLASS III Online-Ausg. Medical instruments and apparatus Management Medical instruments and apparatus Management HEALTH & FITNESS ; Holism HEALTH & FITNESS ; Reference MEDICAL ; Alternative Medicine MEDICAL ; Atlases MEDICAL ; Essays MEDICAL ; Family & General Practice MEDICAL ; Holistic Medicine MEDICAL ; Osteopathy Médecine - Appareils et instruments - Gestion (CaQQLa)201-0015728 Electronic books Electronic books Fiedler, Beth Ann oth 012804179X Erscheint auch als Druck-Ausgabe Managing medical devices within a regulatory framework Amsterdam : Elsevier, 2016, ©2017 https://www.sciencedirect.com/science/book/9780128041796 X:ELSEVIER Verlag lizenzpflichtig http://www.sciencedirect.com/science/book/9780128041796 X:ELSEVIER Verlag Volltext (DE-627)879400137 BSZ-33-EBS-HSAA GBV-33-EBS-MRI GBV-33-EBS-ZHB GBV-33-Freedom-BL ZDB-33-EGE 2016 ZDB-33-EBS ZDB-33-ESD GBV-33-EBS-HST BSZ-33-EBS-C1UB GBV_ILN_105 ISIL_DE-841 SYSFLAG_1 GBV_KXP GBV_ILN_132 ISIL_DE-959 GBV_ILN_185 ISIL_DE-Sra5 GBV_ILN_370 ISIL_DE-1373 GBV_ILN_2020 ISIL_DE-Ch1 GBV_ILN_2111 ISIL_DE-944 GBV ExPruef BO 045F 610.284 045F 610.28/4 105 01 0841 4074406578 OLR-ELV-TEST Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. Testzugang ZHB Lübeck z 26-02-22 132 01 0959 4499994888 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. Zeitlich begrenzte Lizenzierung k 13-03-24 185 01 3519 4514730211 OLR-EBS Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 23-04-24 370 01 4370 4540277103 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. i z 20-06-24 2020 01 DE-Ch1 4520359996 00 --%%-- --%%-- n n Campuslizenz l01 03-05-24 2111 02 DE-944 4046053003 00 --%%-- E-Book Elsevier --%%-- n Elektronischer Volltext - Campuslizenz l01 27-01-22 105 01 0841 http://www.sciencedirect.com/science/book/9780128041796 132 01 0959 Zugriff nur für Angehörige der Hochschule Osnabrück im Hochschulnetz https://www.sciencedirect.com/science/book/9780128041796 185 01 3519 http://www.sciencedirect.com/science/book/9780128041796 370 01 4370 E-Book: Zugriff im HCU-Netz. Zugriff von außerhalb nur für HCU-Angehörige möglich https://www.sciencedirect.com/science/book/9780128041796 2020 01 DE-Ch1 https://www.sciencedirect.com/science/book/9780128041796 2111 02 DE-944 https://www.sciencedirect.com/science/book/9780128041796 132 01 0959 00 EBooks Elsevier Engineering 105 01 0841 OLR-ELV-TEST 132 01 0959 EBS Elsevier 185 01 3519 OLR-EBS 370 01 4370 EBS Elsevier |
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3.6.1 CLINICAL EVALUATION AND IDE SUBMISSION3.7 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 4 -- Manufacturing/Distribution Considerations; 4.1 INTRODUCTION; 4.2 US PRECLINICAL STAGE; 4.2.1 PRODUCT LIFE CYCLE MANAGEMENT; 4.2.2 CURRENT GOOD MANUFACTURING PRACTICES; 4.3 US POSTMARKET STAGE; 4.3.1 ADVERSE EVENT MEDICAL DEVICE REPORTING; 4.3.2 POSTMARKETING 522 STUDIES; 4.3.3 REIMBURSEMENT; 4.4 EUROPEAN UNION CE MARKING: PREMARKETING STAGE; 4.4.1 CE MARKING; 4.4.2 NOTIFIED BODY BEST PRACTICES; 4.5 EU POSTMARKET STAGE; 4.5.1 ADVERSE EVENT MEDICAL DEVICE REPORTING 4.5.2 POSTMARKETING STUDIES4.5.3 REIMBURSEMENT; 4.6 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 2 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5.1 INTRODUCTION; 5.2 BIOCOMPATIBILITY; 5.2.1 ISO AND OTHER RESOURCE GUIDANCE; 5.2.2 CROSS-FUNCTIONAL KNOWLEDGE BASE REPOSITORIES; 5.2.2.1 The Front End of Medical Device Development in the Product Life Cycle; 5.2.2.2 The Back End of Medical Device Development in the Product Life Cycle Front Cover; Managing Medical Devices within a Regulatory Framework; Related titles; Managing Medical Devices within a Regulatory Framework; Copyright; Dedication; Contents; List of Contributors; Foreword; Preface; 1 -- Medical Device Development and Regulatory Overview; 1 -- Reframing Product Life Cycle for Medical Devices; 1.1 INTRODUCTION; 1.2 FDA TOTAL PRODUCT LIFE CYCLE; 1.2.1 CONCEPTION; 1.2.2 PROTOTYPE; 1.2.3 PRECLINICAL INVESTIGATION; 1.2.4 ADVANCED CLINICAL/POSTMARKETING STUDIES; 1.2.5 END OF LIFE; 1.3 EUROPEAN COMMISSION PRODUCT LIFE CYCLE; 1.4 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING2 -- Overview of Medical Device Clinical Trials; 2.1 INTRODUCTION; 2.2 MEDICAL DEVICE SUBMISSIONS OVERVIEW; 2.3 MEDICAL DEVICE CLINICAL TRIALS; 2.3.1 INVESTIGATIONAL DEVICE EXEMPTION; 2.3.2 CLINICAL TRIALS; 2.3.3 MANUFACTURING AND ADDITIONAL STANDARDS; 2.4 REGULATORY PROFILE OF THE US MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.4.1 CLASS I MEDICAL DEVICES; 2.4.2 CLASS II MEDICAL DEVICES; 2.4.3 CLASS III MEDICAL DEVICES; 2.5 REGULATORY PROFILE OF THE EU MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.6 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING3 -- Review Regulatory Guidelines by Device Classification Type; 3.1 INTRODUCTION; 3.2 BASIC OVERVIEW OF THE PREMARKET NOTIFICATION 510(K); 3.2.1 TYPES OF 510(K); 3.2.2 PRIMARY 510(K) SUBMISSION STEPS; 3.2.3 SUBSTANTIAL EQUIVALENCE; 3.3 PREMARKET APPROVAL APPLICATION REGULATORY PATH; 3.3.1 PMA TYPES; 3.3.2 PRESUBMISSION INTERACTION; 3.3.3 PMA FOOD AND DRUG ADMINISTRATION REVIEWS; 3.3.4 PRE-INVESTIGATIONAL DEVICE EXEMPTION SUBMISSION; 3.4 Medical Device Class I; 3.5 MEDICAL DEVICE CLASS II; 3.6 MEDICAL DEVICE CLASS III Print version record |
| abstractGer |
3.6.1 CLINICAL EVALUATION AND IDE SUBMISSION3.7 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 4 -- Manufacturing/Distribution Considerations; 4.1 INTRODUCTION; 4.2 US PRECLINICAL STAGE; 4.2.1 PRODUCT LIFE CYCLE MANAGEMENT; 4.2.2 CURRENT GOOD MANUFACTURING PRACTICES; 4.3 US POSTMARKET STAGE; 4.3.1 ADVERSE EVENT MEDICAL DEVICE REPORTING; 4.3.2 POSTMARKETING 522 STUDIES; 4.3.3 REIMBURSEMENT; 4.4 EUROPEAN UNION CE MARKING: PREMARKETING STAGE; 4.4.1 CE MARKING; 4.4.2 NOTIFIED BODY BEST PRACTICES; 4.5 EU POSTMARKET STAGE; 4.5.1 ADVERSE EVENT MEDICAL DEVICE REPORTING 4.5.2 POSTMARKETING STUDIES4.5.3 REIMBURSEMENT; 4.6 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 2 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5.1 INTRODUCTION; 5.2 BIOCOMPATIBILITY; 5.2.1 ISO AND OTHER RESOURCE GUIDANCE; 5.2.2 CROSS-FUNCTIONAL KNOWLEDGE BASE REPOSITORIES; 5.2.2.1 The Front End of Medical Device Development in the Product Life Cycle; 5.2.2.2 The Back End of Medical Device Development in the Product Life Cycle Front Cover; Managing Medical Devices within a Regulatory Framework; Related titles; Managing Medical Devices within a Regulatory Framework; Copyright; Dedication; Contents; List of Contributors; Foreword; Preface; 1 -- Medical Device Development and Regulatory Overview; 1 -- Reframing Product Life Cycle for Medical Devices; 1.1 INTRODUCTION; 1.2 FDA TOTAL PRODUCT LIFE CYCLE; 1.2.1 CONCEPTION; 1.2.2 PROTOTYPE; 1.2.3 PRECLINICAL INVESTIGATION; 1.2.4 ADVANCED CLINICAL/POSTMARKETING STUDIES; 1.2.5 END OF LIFE; 1.3 EUROPEAN COMMISSION PRODUCT LIFE CYCLE; 1.4 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING2 -- Overview of Medical Device Clinical Trials; 2.1 INTRODUCTION; 2.2 MEDICAL DEVICE SUBMISSIONS OVERVIEW; 2.3 MEDICAL DEVICE CLINICAL TRIALS; 2.3.1 INVESTIGATIONAL DEVICE EXEMPTION; 2.3.2 CLINICAL TRIALS; 2.3.3 MANUFACTURING AND ADDITIONAL STANDARDS; 2.4 REGULATORY PROFILE OF THE US MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.4.1 CLASS I MEDICAL DEVICES; 2.4.2 CLASS II MEDICAL DEVICES; 2.4.3 CLASS III MEDICAL DEVICES; 2.5 REGULATORY PROFILE OF THE EU MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.6 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING3 -- Review Regulatory Guidelines by Device Classification Type; 3.1 INTRODUCTION; 3.2 BASIC OVERVIEW OF THE PREMARKET NOTIFICATION 510(K); 3.2.1 TYPES OF 510(K); 3.2.2 PRIMARY 510(K) SUBMISSION STEPS; 3.2.3 SUBSTANTIAL EQUIVALENCE; 3.3 PREMARKET APPROVAL APPLICATION REGULATORY PATH; 3.3.1 PMA TYPES; 3.3.2 PRESUBMISSION INTERACTION; 3.3.3 PMA FOOD AND DRUG ADMINISTRATION REVIEWS; 3.3.4 PRE-INVESTIGATIONAL DEVICE EXEMPTION SUBMISSION; 3.4 Medical Device Class I; 3.5 MEDICAL DEVICE CLASS II; 3.6 MEDICAL DEVICE CLASS III Print version record |
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3.6.1 CLINICAL EVALUATION AND IDE SUBMISSION3.7 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 4 -- Manufacturing/Distribution Considerations; 4.1 INTRODUCTION; 4.2 US PRECLINICAL STAGE; 4.2.1 PRODUCT LIFE CYCLE MANAGEMENT; 4.2.2 CURRENT GOOD MANUFACTURING PRACTICES; 4.3 US POSTMARKET STAGE; 4.3.1 ADVERSE EVENT MEDICAL DEVICE REPORTING; 4.3.2 POSTMARKETING 522 STUDIES; 4.3.3 REIMBURSEMENT; 4.4 EUROPEAN UNION CE MARKING: PREMARKETING STAGE; 4.4.1 CE MARKING; 4.4.2 NOTIFIED BODY BEST PRACTICES; 4.5 EU POSTMARKET STAGE; 4.5.1 ADVERSE EVENT MEDICAL DEVICE REPORTING 4.5.2 POSTMARKETING STUDIES4.5.3 REIMBURSEMENT; 4.6 SUMMARY; DEFINITIONS; REFERENCES; RECOMMENDATIONS FOR ADDITIONAL READING; 2 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5 -- Defining and Meeting Regulatory Challenges in Clinical Engineering; 5.1 INTRODUCTION; 5.2 BIOCOMPATIBILITY; 5.2.1 ISO AND OTHER RESOURCE GUIDANCE; 5.2.2 CROSS-FUNCTIONAL KNOWLEDGE BASE REPOSITORIES; 5.2.2.1 The Front End of Medical Device Development in the Product Life Cycle; 5.2.2.2 The Back End of Medical Device Development in the Product Life Cycle Front Cover; Managing Medical Devices within a Regulatory Framework; Related titles; Managing Medical Devices within a Regulatory Framework; Copyright; Dedication; Contents; List of Contributors; Foreword; Preface; 1 -- Medical Device Development and Regulatory Overview; 1 -- Reframing Product Life Cycle for Medical Devices; 1.1 INTRODUCTION; 1.2 FDA TOTAL PRODUCT LIFE CYCLE; 1.2.1 CONCEPTION; 1.2.2 PROTOTYPE; 1.2.3 PRECLINICAL INVESTIGATION; 1.2.4 ADVANCED CLINICAL/POSTMARKETING STUDIES; 1.2.5 END OF LIFE; 1.3 EUROPEAN COMMISSION PRODUCT LIFE CYCLE; 1.4 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING2 -- Overview of Medical Device Clinical Trials; 2.1 INTRODUCTION; 2.2 MEDICAL DEVICE SUBMISSIONS OVERVIEW; 2.3 MEDICAL DEVICE CLINICAL TRIALS; 2.3.1 INVESTIGATIONAL DEVICE EXEMPTION; 2.3.2 CLINICAL TRIALS; 2.3.3 MANUFACTURING AND ADDITIONAL STANDARDS; 2.4 REGULATORY PROFILE OF THE US MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.4.1 CLASS I MEDICAL DEVICES; 2.4.2 CLASS II MEDICAL DEVICES; 2.4.3 CLASS III MEDICAL DEVICES; 2.5 REGULATORY PROFILE OF THE EU MEDICAL DEVICE BY CLASSIFICATION TYPE; 2.6 SUMMARY; DEFINITIONS; REFERENCES RECOMMENDATIONS FOR ADDITIONAL READING3 -- Review Regulatory Guidelines by Device Classification Type; 3.1 INTRODUCTION; 3.2 BASIC OVERVIEW OF THE PREMARKET NOTIFICATION 510(K); 3.2.1 TYPES OF 510(K); 3.2.2 PRIMARY 510(K) SUBMISSION STEPS; 3.2.3 SUBSTANTIAL EQUIVALENCE; 3.3 PREMARKET APPROVAL APPLICATION REGULATORY PATH; 3.3.1 PMA TYPES; 3.3.2 PRESUBMISSION INTERACTION; 3.3.3 PMA FOOD AND DRUG ADMINISTRATION REVIEWS; 3.3.4 PRE-INVESTIGATIONAL DEVICE EXEMPTION SUBMISSION; 3.4 Medical Device Class I; 3.5 MEDICAL DEVICE CLASS II; 3.6 MEDICAL DEVICE CLASS III Print version record |
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