Table of Contents Adverse Event Reporting SOPs for Medical Devices

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Page 2 of 122 Table of Contents Adverse Event Reporting SOPs for Medical Devices Previous Teleconferences About SOPs... 7 Dr. Sharlin's Credentials... 8 Outline Of This Presentation... 9 CDRH Requirements for Written Medical Device Reporting (MDR) Procedures 10 Common Compliance Problems with SOPs... 11 Purpose and Benefits of SOPs... 12 Summary of SOP Development, Flowchart... 13 Summary of SOP Development, Flowchart (2)... 14 Summary of SOP Development, Flowchart (3)... 15 The Six Most Common Statistical Errors - From CDRH... 16 How Reviewers Examine Safety Data... 17 How Reviewers Examine Safety Data (2)... 18 A Reviewer s Five Sources of Information for a Safety Review... 19 Ten Ways To Improve A Submission Using Information From the Reviewer Guidance on Evaluating Safety Data... 20 Ten Ways To Improve A Submission Using Information From the Reviewer Guidance on Evaluating Safety Data (2)... 21 Overview Flowchart of AE Reporting Before A Medical Device is Approved IDE Regulations... 22 2

Page 3 of 122 Overview of AE Reporting Before A Medical Device is Approved -- PMA Requirements For Safety Data... 23 Overview of AE Reporting After A Medical Device is Approved Postmarket Surveillance, 21 CFR 822... 24 Overview of AE Reporting After A Medical Device is Approved Medical Device Reporting (MDR)... 25 Voluntary Device Reporting By Health Professionals... 26 Voluntary Device Reporting By Health Professionals (2)... 27 Mandatory Device Reporting By Health Professionals... 28 How FDA Uses MedWatch Data... 29 April 2007 Guidance for Clinical Investigators, Sponsors and IRBs; AE Reporting Improving Human Subject Protection (problem statement and participants).. 30 Flowchart of Current AE Reporting Relationships For Drugs & Biologics... 31 Flowchart of FDA Recommended AE Reporting Relationships For Drugs & Biologics... 32 Flowchart of Current AE Reporting Relationships For Medical Devices... 33 Conclusions From April 2007 Guidance for Clinical Investigators, Sponsors and IRBs; AE Reporting Improving Human Subject Protection... 34 SOP Format: Section Headings... 35 SOP Format: Details... 36 How to Change Model SOPs... 37 Five Required Activities For Each New SOP... 38 Factors That Affect Modification of Model SOPs... 39 3

Page 4 of 122 Six Features of Model SOPs... 40 How To Use SOP Deliverables... 41 33 Definitions Applicable to Medical Device Reporting (MDR)... 42 33 Definitions Applicable to Medical Device Reporting (2)... 43 33 Definitions Applicable to Medical Device Reporting (3)... 44 33 Definitions Applicable to Medical Device Reporting (4)... 45 33 Definitions Applicable to Medical Device Reporting (5)... 46 33 Definitions Applicable to Medical Device Reporting (6)... 47 33 Definitions Applicable to Medical Device Reporting (7)... 48 33 Definitions Applicable to Medical Device Reporting (8)... 49 33 Definitions Applicable to Medical Device Reporting (9)... 50 33 Definitions Applicable to Medical Device Reporting (10)... 51 33 Definitions Applicable to Medical Device Reporting (11)... 51 33 Definitions Applicable to Medical Device Reporting (12)... 53 33 Definitions Applicable to Medical Device Reporting (13)... 53 Model SOP #1, AE Reporting Before a Device is Approved... 55 Model SOP #2, MDR Requirements for Device User Facilities... 56 Model SOP #2, MDR Requirements for Device User Facilities (2)... 57 Model SOP #2, MDR Requirements for Device User Facilities (3)... 58 Model SOP #3, MDR Requirements for Device Importers... 59 4

Page 5 of 122 Model SOP #3, MDR Requirements for Device Importers (2)... 60 Model SOP #4, MDR Requirements for Device Manufacturers... 61 Model SOP #4, MDR Requirements for Device Manufacturers (2)... 62 Model SOP #4, MDR Requirements for Device Manufacturers (3)... 63 Model SOP #4, MDR Requirements for Device Manufacturers (4)... 64 Model SOP #4, MDR Requirements for Device Manufacturers (5)... 65 Model SOP #5, Medical Device Complaint Records... 66 Model SOP #5, Medical Device Complaint Records (2)... 67 Model SOP #6, Validation of AE Data Capture Systems... 69 Model SOP #7, Data Monitoring Committee... 70 Model SOP #8, Statistical Analysis of AE Data... 71 Model SOP #9, MedDRA Coding of AE Data... 72 Summary of Audioconference; Adverse Event Reporting SOPs for Devices... 73 Joshua Sharlin, Ph.D., Resume... 74 SOP #1, AE Reporting Before a Device is Approved (text)... 76 SOP #2, MDR Requirements for Device User Facilities (text)... 84 SOP #3, MDR Requirements for Device Importers (text)... 88 SOP #4, MDR Requirements for Device Manufacturers (text)... 92 SOP #5, Complaint Records (text)... 97 SOP #6, Validation of Electronic AE Data Capture Systems (text)... 101 5

Page 6 of 122 SOP #7, Data Monitoring Committee (text)... 107 SOP #8, Statistical Analysis of AE Data (text)... 113 SOP #9, MedDRA Coding of AE Data (text)... 119 6

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