1. 21 CFR PART 11 REGULATIONS RECOMMENDATIONS FOR CHANGES FDA PUBLIC MEETING ON PART 11 REGULATIONS – JUNE 11, 2004 NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION (NEMA) RICHARD EATON - NEMA RAVI NABAR, PH.D. – EASTMAN KODAK

2. National Electrical Manufacturers Association (NEMA) - Largest U.S. trade association representing America’s electroindustry - Diagnostic Imaging and Therapy Systems Division of NEMA represents manufacturers of: X-ray, CT, diagnostic ultrasound, magnetic resonance, nuclear medicine imaging, radiation therapy and medical imaging informatics equipment - Member of Part 11 Coalition

3. OVERVIEW - Original intended objectives of Part 11 Regulations - “The Problem” – Part 11 Duplication of Predicate Rules - NEMA presentation addresses Question 3 – Part 11 Subpart B Electronic Records - Proposed Solution

4. Original intended key objectives of Part 11 Regulations - Retention/documentation of records - Integrity/security of Records - FDA Access to Records - Authentication of Electronic Signatures - Accountability for Maintaining Records System - Validation

5. “THE PROBLEM” DUPLICATION – PART 11 AND PREDICATE RULES - Part 11 Regulations’ Objectives covered by Predicate Rules - Part 11 Regulations are too prescriptive - Part 11 Regulations + Predicate Rules – Duplicative and Confusing - Duplicative Regulations are Contrary to “least burdensome” principles to minimize excess regulation

6. PROPOSED SOLUTIONS ALTERNATIVE A: – Withdraw Part 11 Regulations in favor of Predicate Rules ALTERNATIVE B: – Change Part 11 Regulations to “Guidance” document

7. PREDICATE RULES ADDRESS PART 11 OBJECTIVES PREDICATE RULES ADDRESS PART 11 OBJECTIVES - Quality System Regulation - Medical Device Reporting - Corrections and Removals - Good Laboratory Practices

8. QUALITY SYSTEM REGULATION DUPLICATED BY PART 11 REGS. * PART 11 REGS. - 21 CFR 11.10(a) Validation of Systems - 21 CFR 11.10(b) Controls – Closed Systems -Generate copies of records for inspection - 21 CFR 11.10(c) Protection of Records to enable retrieval LIMIT ACCESS TO AUTHORIZED INDIVIDUALS OPERATIONAL SYSTEM CHECKS QSR REGULATION - 21 CFR 820.70 (i) Production/Process Controls - 21 CFR 820.40 – Document Controls - 21 CFR 820.180 – General Requirements - 21 CFR 820.40, 820.180 * Intent of Predicate Rules is the same as Part 11 Regulations, but less prescriptive

9. QUALITY SYSTEM REGULATION DUPLICATED BY PART 11 REGS. PART 11 REGS. -21 CFR 11.10(d) Limit Access to authorized individuals -21 CFR 11.10(e) Use of computer-generated audit trails QSR REGULATION -21 CFR 820.40 Document Controls -21 CFR 820.20 Mgmt. Responsibility -21 CFR 820.40 Document Controls

10. QUALITY SYSTEM REGULATION COMPARED WITH PART 11 REGS. Part 11 REGS. -21 CFR 11.10(f) Operational checks -21 CFR 11.10(g) Authority checks -21 CFR 11.10(h) Device checks QSR REGULATION -21 CFR 820.70 Prod./Process control -21 CFR 820.20 Mgmt. responsibility -21 CFR 820.25 Personnel

11. QUALITY SYSTEM REGULATION DUPLICATED BY PART 11 REGS. PART 11 REGS. -21 CFR 11.10(i) Education - personnel -21 CFR 11.10(j) Accountability -21 CFR 11.10(k) Controls – system documentation QSR REGULATION -21 CFR 820.25 Personnel -21 CFR 820.20 Mgmt. Responsibility -21 CFR 820.40 Document Controls

12. MEDICAL DEVICE REPORTING REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10(b) Controls – generate copies of records for inspection - 21 CFR 11.10(c) Protection of records to enable retrieval MDR REGULATION - 21 CFR 803.1 Maintain Records

13. MEDICAL DEVICE REPORTING REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10(b) Controls - 21 CFR 11.10(b) Controls - 21 CFR 11.10(k) Controls – System Documentation MDR REGULATION - 21 CFR 803.10 Required Reports - 21 CFR 803.14 Electronic Reporting - 21 CFR 803.17 Written MDR Procedures

14. MEDICAL DEVICE REPORTING REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10(e) Audit trails - 21 CFR 11.10(k) Controls – system documentation MDR REGULATION - 21 CFR 803.18 File/Distributor Reports (MDR events)

15. CORRECTIONS AND REMOVALS REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10(b) Controls - 21 CFR 11.10 (c) Protection of Records CORRECT. AND REMOVALS REG. - 21 CFR 806.1 Maintain Records

16. CORRECTIONS AND REMOVALS REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10(b) Controls CORRECT. AND REMOVALS REG. - 21 CFR 806.10 Corrections and Removals Reports

17. CORRECTIONS AND REMOVALS REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10(b) Controls CORRECT. AND REMOVALS REG. - 21 CFR 806.30 FDA Access to Records

18. GOOD LABORATORY PRACTICE REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10(b) Records for inspection - 21 CFR 11.10(i) Education/training of personnel GOOD LAB. PRACTICE REG. - 21 CFR 58.15 Inspection of records - 21 CFR 58.29 Personnel – education and training

19. GOOD LABORATORY PRACTICE REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10 ( c ) Protection of records - 21 CFR 11.10 (k) Appropriate controls over system documentation GOOD LAB. PRACTICE REG. - 21 CFR 58.33 Study Director – responsibility for documentation

20. GOOD LABORATORY PRACTICE REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10(g) authority system checks - 21 CFR 11.10(k) Appropriate controls over system documentation - 21 CFR 11.30 Controls over open systems GOOD LAB. PRACTICE REG. - 21 CFR 58.35 Quality Assurance Unit

21. GOOD LABORATORY PRACTICE REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10 ( c ) Controls over system documentation GOOD LAB. PRACTICE REG. - 21 CFR 58.81 Written standard operating procedures

22. GOOD LABORATORY PRACTICE REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10(c) Protection of records - 21 CFR 11.10(k) Appropriate controls over system documentation GOOD LAB. PRACTICE REG. - 21 CFR 59.190 Storage and retrieval of records

23. GOOD LABORATORY PRACTICE REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS. - 21 CFR 11.10( c) Protection of records - 21 CFR 11.10(k) Appropriate controls for system documentation GOOD LAB. PRACTICE REG. - 21 CFR 58.195 Retention of records

24. PREDICATE RULES - Acceptance by FDA and Industry - Part of Established Product Approval Process - Part of Long-Established Medical Device GMP Practice - Adequately Protects Public Health - Comprehensive – Covers all phases of product design, development, manufacture and correction and problem reporting

25. CONCLUSION AND RECOMMENDATIONS - Part 11 Rules are duplicative, burdensome and too prescriptive - Withdraw Part 11 Regulations in favor of predicate rules - Convert Part 11 Regulations to a less prescriptive, risk-based guidance document - NEMA ‘s goal is to work with FDA to achieve a practical regulatory solution which will meet the objectives of both FDA and industry