21 CFR PART 11 REGULATIONS21 CFR PART 11 REGULATIONSRECOMMENDATIONS FOR CHANGESRECOMMENDATIONS FOR CHANGES

FDA PUBLIC MEETING ON PART 11 FDA PUBLIC MEETING ON PART 11 REGULATIONS – JUNE 11, 2004REGULATIONS – JUNE 11, 2004

NATIONAL ELECTRICAL MANUFACTURERS

ASSOCIATION (NEMA)

RICHARD EATON - NEMA

RAVI NABAR, PH.D. – EASTMAN KODAK

National Electrical Manufacturers National Electrical Manufacturers Association (NEMA)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

OVERVIEWOVERVIEW

- 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 Original intended key objectives of Part 11 RegulationsPart 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”THE PROBLEM”DUPLICATION – PART 11 AND DUPLICATION – PART 11 AND

PREDICATE RULESPREDICATE 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 SOLUTIONSPROPOSED SOLUTIONS

ALTERNATIVE A:– Withdraw Part 11 Regulations in favor of

Predicate Rules

ALTERNATIVE B:– Change Part 11 Regulations to “Guidance”

document

PREDICATE RULES ADDRESS PREDICATE RULES ADDRESS PART 11 OBJECTIVESPART 11 OBJECTIVES

- Quality System Regulation

- Medical Device Reporting

- Corrections and Removals

- Good Laboratory Practices

QUALITY SYSTEM REGULATION QUALITY SYSTEM REGULATION DUPLICATED BY PART 11 REGS. *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

QUALITY SYSTEM REGULATION QUALITY SYSTEM REGULATION DUPLICATED BY PART 11 REGS. 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

QUALITY SYSTEM REGULATIONQUALITY SYSTEM REGULATIONCOMPARED WITH PART 11 REGS.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

QUALITY SYSTEM REGULATIONQUALITY SYSTEM REGULATIONDUPLICATED BY PART 11 REGS.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 820.25Personnel

-21 CFR 820.20Mgmt. Responsibility

-21 CFR 820.40Document Controls

MEDICAL DEVICE REPORTING MEDICAL DEVICE REPORTING REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 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

MEDICAL DEVICE REPORTING MEDICAL DEVICE REPORTING REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 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

MEDICAL DEVICE REPORTING MEDICAL DEVICE REPORTING REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 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)

CORRECTIONS AND REMOVALS CORRECTIONS AND REMOVALS REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 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

CORRECTIONS AND REMOVALS CORRECTIONS AND REMOVALS REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 11 REGULATIONSPART 11 REGS.

- 21 CFR 11.10(b)

Controls

CORRECT. AND REMOVALS REG.

- 21 CFR 806.10

Corrections and Removals Reports

CORRECTIONS AND REMOVALS CORRECTIONS AND REMOVALS REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 11 REGULATIONS

PART 11 REGS.

- 21 CFR 11.10(b)

Controls

CORRECT. AND REMOVALS REG.

- 21 CFR 806.30

FDA Access to Records

GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 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

GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 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

GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 11 REGULATIONSPART 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

GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 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

GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 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

GOOD LABORATORY PRACTICE GOOD LABORATORY PRACTICE REGULATION COMPARED WITH REGULATION COMPARED WITH

PART 11 REGULATIONSPART 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

PREDICATE RULESPREDICATE 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 CONCLUSION AND RECOMMENDATIONSRECOMMENDATIONS

- 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