21 CFR PART 11 REGULATIONS RECOMMENDATIONS FOR CHANGES FDA PUBLIC MEETING ON PART 11 REGULATIONS

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21 CFR PART 11 REGULATIONSRECOMMENDATIONS FOR
CHANGESFDA PUBLIC MEETING ON PART 11
REGULATIONS JUNE 11, 2004

• NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION
  (NEMA)
• RICHARD EATON - NEMA
• RAVI NABAR, PH.D. EASTMAN KODAK

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National Electrical Manufacturers Association
(NEMA)

• - Largest U.S. trade association representing
  Americas 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

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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

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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

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THE PROBLEMDUPLICATION 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

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PROPOSED SOLUTIONS

• ALTERNATIVE A
• Withdraw Part 11 Regulations in favor of
  Predicate Rules
• ALTERNATIVE B
• Change Part 11 Regulations to Guidance document

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PREDICATE RULES ADDRESS PART 11 OBJECTIVES

• - Quality System Regulation
• - Medical Device Reporting
• - Corrections and Removals
• - Good Laboratory Practices

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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

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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

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QUALITY SYSTEM REGULATIONCOMPARED 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

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QUALITY SYSTEM REGULATIONDUPLICATED 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

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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

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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

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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)

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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

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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

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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

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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

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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

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GOOD LABORATORY PRACTICE REGULATION COMPARED WITH
PART 11 REGULATIONS

• GOOD LAB. PRACTICE REG.
• - 21 CFR 58.35
• Quality Assurance Unit

• 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

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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

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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

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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

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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

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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