CONSENSUS STANDARDS

OIVD WORKSHOP
April 22-23, 2003
Rockville MD

Ginette Y. Michaud, M.D.
OIVD

[Powerpoint]

INTRODUCTION

• CDRH recognizes many consensus standards relevant to IVDs
  • IVD SPECIFIC STANDARDS
  • GENERIC DEVICE STANDARDS

INTRODUCTION

IVD SPECIFIC STANDARDS – NCCLS

• automation and informatics
• clinical chemistry and toxicology
• evaluation protocols
• general laboratory practices
• hematology
• immunology and ligand assay
• microbiology
• molecular methods

INTRODUCTION

"GENERIC" DEVICE STANDARDS-
AAMI, ANSI, CEN, IEC, IEEE, ISO, UL

• software
• medical device risk management
• human factors
• electrical safety
• electromagnetic compatibility

INTRODUCTION

CONSENSUS STANDARDS

*Focus on consensus documents

I. Role of consensus standards in IVD premarket review

• FDA Modernization Act of 1997
  • Creates Section 514(c) of the Food, Drug, and Cosmetic Act
    • FDA recognition of national and international standards (Federal Register)
    • voluntary conformance by manufacturers to recognized standards
    • submission of declaration of conformity

I. Role of consensus standards in IVD premarket review

• Conformity with recognized standards may affect:
  • safety and effectiveness determinations
    • IDE, HDE, PMA, PDP
  • substantial equivalence determinations
    • 510(k)/abbreviated
  • amount of test data submitted/reviewed
• Manufacturer obligated to:
  • maintain records
  • submit data upon request

I. Role of consensus standards in IVD premarket review

• Conformance to STNDs is voluntary
• Alternate approaches allowed

Refer to:

• "Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA".
  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfm.

I. Role of consensus standards in IVD premarket review

• Other guidance:
  • "The New 510(k) Paradigm. Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications, Final Guidance."
    and
  • "Frequently Asked Questions on the New 510(k) Paradigm".

II. FDA’s role in the development of consensus standards

• Significant OIVD participation in standards development organizations (SDOs)
  • official membership by individuals
  • informal document reviews

II. FDA’s role in the development of consensus standards

• FDA SDO participation governed by 21CFR10.95 Participation in outside standard-setting activities.
  • FDA encourages participation if in the public interest
  • CDRH supports participation through the CDRH Standards Program
  • Individual participation by invitation

II. FDA’s role in the development of consensus standards

• Organization must meet minimum standards as an SDO:
  • activity based on sound scientific and technological information;
  • revisions on the basis of new information;
  • goal to protect the public against unsafe, ineffective, or deceptive products or practices;
  • activity not for economic benefit of any group;
  • activity not involving specific approval of individual products;
  • existence of commenting procedure.

II. FDA’s role in the development of consensus standards

• FDA official participation restricted to organizations that meet requirements
• Standards are considered for FDA recognition only if developed in conformance with requirements

II. FDA’s role in the development of consensus standards

OIVD participation in standards development:

• NCCLS
• ISO
• GHTF

II. FDA’s role in the development of consensus standards

NCCLS:

• international, voluntary, consensus SDO
• Goal: to "enhance the value of medical testing...through the development and dissemination of standards, guidelines, and best practices"

II. FDA’s role in the development of consensus standards

NCCLS Participation:

• proposal of new standards projects
• committee writing assignments
• commenting on documents
• voting on proposed standards

II. FDA’s role in the development of consensus standards

International Organization for Standardization/ISO:

• Voluntary, consensus SDO; non-governmental federation of national SDOs, covering all technical fields except electrical
• Mission: to promote international standardization to reduce technical barriers to trade

II. FDA’s role in the development of consensus standards

ISO:

• ~200 technical committees each for different technical areas
• OIVD participates in ISO TC 212 Clinical laboratory testing and in vitro diagnostic test systems

II. FDA’s role in the development of consensus standards

ISO TC 212:

• Goal: standardization in laboratory medicine and IVD test systems
• 3 working groups:
  • WG 1    Quality management in the clinical laboratory
  • WG 2    Reference systems
  • WG 3    In vitro diagnostic products

II. FDA’s role in the development of consensus standards

ISO TC 212:

• 4 completed standards:
  • medical laboratory quality and competence
  • reference measurement procedures
  • reference materials
  • labeling of staining reagents

II. FDA’s role in the development of consensus standards

ISO TC 212:

• Standards under development:
  • laboratory safety
  • requirements for reference measurement laboratories
  • metrological traceability

II. FDA’s role in the development of consensus standards

ISO TC 212:

• Documents under development (continued):
  • requirements for blood glucose self-testing systems
  • specifications for self-testing Prothrombin Time instruments
  • quality management of point of care testing

II. FDA’s role in the development of consensus standards

Global Harmonization Task Force (GHTF):

• voluntary multi-national organization
• representatives: medical device regulatory authorities and industry associations

• Goal: harmonization and convergence of medical device regulatory practices

II. FDA’s role in the development of consensus standards

GHTF:

• publishes harmonized documents on regulatory practices & definitions
• for use by emerging economies and developed nations
• 4 Study Groups focused on all phases of product life cycle

II. FDA’s role in the development of consensus standards

GHTF:

• Harmonization projects:
  • premarket regulatory practices,
  • standardized premarket submission format,
  • labeling requirements
  • data collection
  • post-market surveillance reporting systems
  • quality system requirements
  • medical device auditing processes

II. FDA’s role in the development of consensus standards

• CDRH active in all Study Groups (SG); OIVD active in SG 1
• SG1: operational aspects of medical device regulation including IVD products
  • Current IVD harmonization projects:
    • classification
    • labeling
    • IVD premarket conformity with principles for safety and performance

III. Process for FDA Recognition of Consensus Standards

• 62 IVD Standards recognized by CDRH (NCCLS)
• numerous non-IVD standards recognized

III. Process for FDA Recognition of Consensus Standards

• Mechanisms for proposing CDRH recognition of consensus standards:

1. Proposals by CDRH Specialty Task Groups (STG)
2. Proposals submitted by outside persons and considered by STG

• Publication in Federal Register

III. Process for FDA Recognition of Consensus Standards

• Specialty Task Groups:
  • Review previously recognized Standards for relevance
  • Prepare list of priorities for new projects
  • Propose the revision of existing consensus documents

CONCLUSION

• OIVD acknowledges the importance of consensus standards:
  • impact on safety & effectiveness
  • greater premarket requirement transparency
  • review of submissions facilitated
• Active OIVD participation in development & recognition of STNDs

http://www.fda.gov/cdrh/stdsprog.html