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A. Adverse Event Reporting - Global Harmonization Taskforce
1. Adverse event reporting for Medical Devices
2. Comparison of Adverse Event Reports ISO – FDA
3. Guidance on Adverse Event Reporting
4. Guidance on Handling Adverse Event Report Information
5. Post-market vigilance for Medical Devices
6. Timing of Adverse Event Reports
7. Trend Reports for Adverse Events
B. Clinical Investigations
1. Computerized Systems Used in Clinical Trials
2. Financial Disclosure - Clinical Investigators
3. Format for IDE Progress Report
4. Guidance on IDE Policies and Procedures
5. Refuse to Accept Policy
6. Informed Consent - Protection Human Subjects
7. Institutional Review Boards
8. Modifications during a Clinical Investigation
9. Monitoring Clinical Investigations
10. Protection of Human Subjects
11. Suggested Content - IDE Application Cover Letter
C. Corrective - Preventive Actions – CAPA
1. CAPA Guidelines.doc
2. Corrective and Preventive Actions - Training
D. Design Controls
1. Contents of a Product Development Protocol (Draft)
2. Design Control Guidance
3. Design Control Inspection
4. Do-It By Design - Human Factors in Medical Devices
5. Design Control Guidance 6. Human Factors Engineering
E. Device Classification
1. Classify Your Device
2. Device Classification Questionnaire
F. Electronic Signatures - Part 11 Compliance
1. Electronic Signatures & Records - Guidance for Industry
2. Part 11 Requirements
G. Exporting
1. Exporting Medical Devices
H. Forms & Instructions
1. Device Listing
2. Instructions - Device Listing
3. Instructions - Establishment Registration
4. Instructions - Medical Device Listing.
5. Instructions - Medical Device Reporting.
6. Instructions - Medwatch Medical Device Reports.
7. Instructions - Registration of Device Establishment.
8. Medical Device Reporting - Baseline
9. Medical Device Reporting - User Facility
10. Medwatch - MDR Reporting Mandatory
11. Medwatch - Voluntary Reporting
12. Registration of Device Establishment
I. Good Laboratory Practices
1. FAQ Good Lab Practices
2. Good Lab Practices - Compliance Manual
3. Good Laboratory Practices – Non-Clinical
4. Good Laboratory Practices Handbook
J. Internal Quality Auditing
1. Audit Procedure - Example
2. Guidance - Auditing for Medical Device Manufacturers
3. Guidance for Auditing Medical Device Manufacturers
4. Training Requirements for Auditors
K. Investigational Device Exemptions
1. Investigational Device Exemptions
L. Investigations - FDA Operations Manual
1. AppendixA_Food Additives
2. AppendixB_21 CFR Parts
3. AppendixC-H_Misc
4. Chapter1_Administration
5. Chapter10_Reference Materials
6. Chapter2_Organization
7. Chapter3_Federal and State Cooperation
8. Chapter4_Sampling
9. Chapter5_Establishment Inspection
10. Chapter6_Imports
11. Chapter7_Regulatory
12. Chapter8_Recall Activities
13. Chapter9_Investigations
M. Labeling
1. Device Labeling Guidance
2. Labeling for Medical Devices
N. Medical Device Quality System Manual
1-Cover Page Preface Forward
2-Contents
3-QS Regulation
4-Quality Systems
5-Design Controls
6-Process Validation
7-Personnel and Training
8-Buildings and Environment
9-Equipment and Calibration
10-Device Master Records
11-Document and Change Control
12-Purchasing and Acceptance
13-Labeling
14-Packaging
15-Storage Distribution and Installation
16-Complaint Files
17-Servicing
18-Quality System Audits
19-Factory Inspections
20-Product Evaluation 1
21-Product Evaluation 2
22-CGMP Final Rule.htm
23-Computerized devices and manufacturing
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O. Medical Device Reporting – MDR
1. MDR - Alternative Summary Reporting
2. MDR Guidance Remedial Action Exemption
3. MDR Reporting - Final Rule and FAQ
4. Medical Device Reporting - General Information
5. Medical Device Reporting - Overview
6. Medical Device Reporting- Contact Information
7. Medical Device Tracking
8. Medwatch MDR - Codes Manual
9. Medwatch MDR - Common Problems
10. Postmarket Surveillance & Adverse Events
P. Miscellaneous Documents
1. FDA Guidance Documents List
2. FDA Information Links
3. FDA Modernization Act of 1997
4. FDA Site Map
5. Labeling for Medical Devices
Q. Pharmaceutical
1. Pharmaceutical CGMP - Report
2. Pharmaceutical Good Manf. Practice
3. Pharmaceutical Continuous Improvement
4. Pharmaceutical Part 11 - Guidance for Industry
5. Pharmaceutical Quality Assurance
R. Pre-amendment Approval - 510K
1. 510K Application - Cover Sheet
2. 510K Application - Required Elements
3. 510K Application Status Request
4. 510K Decision Process - Detailed
5. 510K Decision Process Overview
6. 510K FAQ - Guidance for Industry
7. 510K Format-Traditional and Abbreviated
8. 510K Guidance - 1986 Version
9. 510K Indications for Use Form
10. 510K Required Format
11. 510K Review Fees
12. 510K Statement - Certification
13. 510K Submission - Required Content
14. 510K Submission Process
15. 510K Truthful and Accurate Statement
16. How To Find A Predicate Device
17. Medical Device Regulations for 510K
18. Pre-amendment Status Proof - Requirements
19. Pre-market Notification Summary
20. Refuse to Accept by FDA Procedures for 510K
21. Use of Published Literature to Support Approvals
22. Using Standards for Equivalence Determinations
S. Pre-market Approval – PMA
1. Acceptance of Foreign Clinical Studies
2. PMA Application - Filing Review
3. PMA Cover Sheet
4. PMA Supplement - Review Request Form
5. Statistical Checklist - PMA Review
T. Process Validation
1. General Principles of Software Validation
2. Process Validation Guidance
U. Quality System Inspection Technique – QSIT
1. Criteria for Third party FDA Inspections
2. FDA Inspection Information
3. Likelihood of Inspections
4. QSIT CAPA Inspections
5. QSIT Design & Process Controls
6. QSIT Inspection GUIDE
7. QSIT Inspection Technique - Workshop
8. QSIT Inspection Technique Guide
9. QSIT Management Controls
10. QSIT Overview - Welch
11. QSIT Overview - Trautman
12. Quality System Framework - Staff Manual
V. Quality System Regulation – QSR
1. 21 CFR 820 - FDA Quality System Regulation
2. Good Manufacturing Practice for Combination Products
3. Medical Device - Classes
4. Medical Device Exemptions
5. QSR Implementation Outline
6. Quality Systems for Medical Devices
7. Safety and Performance for Medical Devices
W. Recalls
1. Medical Device Recalls and Corrections and Removals
2. Recall effectiveness checks
X. Regulatory Procedures Manual
1. Appendix Change Request Form
2. Chapter 1 Regulatory Organization
3. Chapter 10 Other Procedures
4. Chapter 11 Glossary
5. Chapter 2 FDA Authority
6. Chapter 3 Commissioning Work Sharing
7. Chapter 4 Advisory Actions
8. Chapter 5 Administrative Actions
9. Chapter 6 Judicial Actions
10. Chapter 7 Recall Procedures
11. Chapter 8 Emergency Procedures
12. Chapter 9 Import Procedures
13. Introduction
Y. Software Regulations & Guidance
1. Cyber security for Networked Medical Devices
2. General Principles of Software Validation
3. Guidance – Pre-market submissions for software in medical devices
4. Off-The-Shelf Software for Medical Devices
Z. Standards
1. Standards Development - Organizations
2. Standards in Assessment of Medical Devices
3. Using Standards for Equivalence Determinations
AA. User Fees
1. Small Business Qualification Worksheet
2. User Fees - 510K Applications
3. User Fees - Combination Products
4. User Fees - Multiple Documents
5. User Fees – Pre-market Approval
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