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.
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.
