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

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

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

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

“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

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

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

QUALITY SYSTEM REGULATION DUPLICATED BY PART 11 REGS. * PART 11 REGS 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 (i) Production/Process Controls - 21 CFR – Document Controls - 21 CFR – General Requirements - 21 CFR , * Intent of Predicate Rules is the same as Part 11 Regulations, but less prescriptive

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 Document Controls -21 CFR Mgmt. Responsibility -21 CFR Document Controls

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 Prod./Process control -21 CFR Mgmt. responsibility -21 CFR Personnel

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 Personnel -21 CFR Mgmt. Responsibility -21 CFR Document Controls

MEDICAL DEVICE REPORTING REGULATION COMPARED WITH PART 11 REGULATIONS PART 11 REGS 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 Maintain Records

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

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

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

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

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

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

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

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

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

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

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

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

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