1 consensus standards oivd workshop april 22-23, 2003 rockville md ginette y. michaud, m.d. oivd

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CONSENSUS CONSENSUS STANDARDSSTANDARDS

OIVD WORKSHOPOIVD WORKSHOPApril 22-23, 2003April 22-23, 2003

Rockville MDRockville MD

Ginette Y. Michaud, M.D.Ginette Y. Michaud, M.D.OIVDOIVD

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INTRODUCTIONINTRODUCTION

CDRH recognizes many consensus CDRH recognizes many consensus standards relevant to IVDsstandards relevant to IVDs

IVD SPECIFIC STANDARDSIVD SPECIFIC STANDARDS

GENERIC DEVICE STANDARDSGENERIC DEVICE STANDARDS

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IVD SPECIFIC STANDARDS – NCCLSIVD SPECIFIC STANDARDS – NCCLSautomation and informatics automation and informatics clinical chemistry and toxicologyclinical chemistry and toxicologyevaluation protocolsevaluation protocolsgeneral laboratory practicesgeneral laboratory practiceshematologyhematologyimmunology and ligand assayimmunology and ligand assaymicrobiologymicrobiologymolecular methodsmolecular methods

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““GENERIC” DEVICE STANDARDS-GENERIC” DEVICE STANDARDS-

AAMI, ANSI, CEN, IEC, IEEE, ISO, UL AAMI, ANSI, CEN, IEC, IEEE, ISO, UL softwaresoftwaremedical device risk managementmedical device risk managementhuman factorshuman factorselectrical safety electrical safety electromagnetic compatibility electromagnetic compatibility

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CONSENSUS STANDARDSCONSENSUS STANDARDS

I. Role of consensus standards in IVD I. Role of consensus standards in IVD premarket review premarket review

II. FDA’s role in development of STNDsII. FDA’s role in development of STNDs

III. Process for FDA recognition of STNDsIII. Process for FDA recognition of STNDs

*Focus on consensus documents*Focus on consensus documents

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I. Role of consensus standards I. Role of consensus standards in IVD in IVD premarket reviewpremarket review FDA Modernization Act of 1997FDA Modernization Act of 1997

– Creates Section 514(c) of the Food, Creates Section 514(c) of the Food, Drug, and Cosmetic Act Drug, and Cosmetic Act

FDA recognition of national and FDA recognition of national and international standards (Federal international standards (Federal Register)Register)

voluntary conformance by manufacturers voluntary conformance by manufacturers to recognized standardsto recognized standards

submission of declaration of conformitysubmission of declaration of conformity

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I. Role of consensus standards I. Role of consensus standards in IVD in IVD

premarket reviewpremarket review Conformity with recognized standards may Conformity with recognized standards may

affect:affect:safety and effectiveness determinationssafety and effectiveness determinations

IDE, HDE, PMA, PDPIDE, HDE, PMA, PDP substantial equivalence determinationssubstantial equivalence determinations

510(k)/abbreviated510(k)/abbreviated amount of test data submitted/reviewedamount of test data submitted/reviewed

Manufacturer obligated to:Manufacturer obligated to: maintain recordsmaintain records submit data upon requestsubmit data upon request

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premarket reviewpremarket review Conformance to STNDs is voluntaryConformance to STNDs is voluntary Alternate approaches allowedAlternate approaches allowed

Refer to:Refer to: "Recognition and Use of Consensus "Recognition and Use of Consensus

Standards; Final Guidance for Industry and Standards; Final Guidance for Industry and FDA"FDA". . http://www.accessdata.fda.gov/scripts/cdrhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfmh/cfdocs/cfggp/search.cfm..

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premarket reviewpremarket review Other guidance:Other guidance:

"The New 510(k) Paradigm. Alternate "The New 510(k) Paradigm. Alternate Approaches to Demonstrating Approaches to Demonstrating Substantial Equivalence in Premarket Substantial Equivalence in Premarket Notifications, Final Guidance." Notifications, Final Guidance."

and and

"Frequently Asked Questions on the "Frequently Asked Questions on the New 510(k) Paradigm"New 510(k) Paradigm". .

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

Significant OIVD participation in Significant OIVD participation in standards development standards development organizations (SDOs)organizations (SDOs)

official membership by individualsofficial membership by individuals informal document reviewsinformal document reviews

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FDA SDO participation governed by FDA SDO participation governed by 21CFR10.95 Participation in outside 21CFR10.95 Participation in outside standard-setting activitiesstandard-setting activities. .

– FDA encourages participation if in the FDA encourages participation if in the public interestpublic interest

– CDRH supports participation through the CDRH supports participation through the CDRH Standards ProgramCDRH Standards Program

– Individual participation by invitationIndividual participation by invitation

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Organization must meet minimum Organization must meet minimum standards as an SDO:standards as an SDO:– activity based on sound scientific and activity based on sound scientific and

technological information; technological information; – revisions on the basis of new information; revisions on the basis of new information; – goal to protect the public against unsafe, goal to protect the public against unsafe,

ineffective, or deceptive products or practices;ineffective, or deceptive products or practices;– activity not for economic benefit of any group;activity not for economic benefit of any group;– activity not involving specific approval of activity not involving specific approval of

individual products;individual products;– existence of commenting procedure. existence of commenting procedure.

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FDA official participation restricted to FDA official participation restricted to organizations that meet organizations that meet requirements requirements

Standards are considered for FDA Standards are considered for FDA recognition only if developed in recognition only if developed in conformance with requirementsconformance with requirements

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OIVD participation in standards OIVD participation in standards development: development:

NCCLS NCCLS ISOISOGHTFGHTF

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NCCLS:NCCLS: international, voluntary, consensus international, voluntary, consensus

SDO SDO Goal: to “enhance the value of Goal: to “enhance the value of

medical testing...through the medical testing...through the development and dissemination of development and dissemination of standards, guidelines, and best standards, guidelines, and best practices” practices”

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NCCLS Participation:NCCLS Participation:

proposal of new standards projectsproposal of new standards projects committee writing assignmentscommittee writing assignments commenting on documentscommenting on documents voting on proposed standardsvoting on proposed standards

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International Organization for International Organization for Standardization/ISO:Standardization/ISO:

Voluntary, consensus SDO; non-Voluntary, consensus SDO; non-governmental federation of national SDOs, governmental federation of national SDOs, covering all technical fields except covering all technical fields except electricalelectrical

Mission: to promote international Mission: to promote international standardization to reduce technical standardization to reduce technical barriers to trade barriers to trade

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ISO:ISO:

~200 technical committees each for ~200 technical committees each for different technical areasdifferent technical areas

OIVD participates in ISO TC 212 OIVD participates in ISO TC 212 Clinical laboratory testing and in vitro Clinical laboratory testing and in vitro diagnostic test systemsdiagnostic test systems

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ISO TC 212: ISO TC 212: Goal: standardization in laboratory Goal: standardization in laboratory

medicine and IVD test systemsmedicine and IVD test systems 3 working groups:3 working groups:

– WG 1WG 1 Quality management in Quality management in the the clinical laboratory clinical laboratory

– WG 2 WG 2 Reference systemsReference systems– WG 3 WG 3 In vitro diagnostic productsIn vitro diagnostic products

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ISO TC 212: ISO TC 212: 4 completed standards: 4 completed standards:

– medical laboratory quality and medical laboratory quality and competencecompetence

– reference measurement proceduresreference measurement procedures– reference materialsreference materials– labeling of staining reagentslabeling of staining reagents

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ISO TC 212: ISO TC 212: Standards under development:Standards under development:

laboratory safety laboratory safety requirements for reference requirements for reference

measurement laboratories measurement laboratories metrological traceabilitymetrological traceability

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ISO TC 212: ISO TC 212: Documents under development Documents under development

(continued):(continued):requirements for blood glucose self-requirements for blood glucose self-

testing systems testing systems specifications for self-testing specifications for self-testing

Prothrombin Time instruments Prothrombin Time instruments quality management of point of care quality management of point of care

testingtesting

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Global Harmonization Task Force Global Harmonization Task Force (GHTF):(GHTF):

voluntary multi-national organizationvoluntary multi-national organization representatives: medical device representatives: medical device

regulatory authorities and industry regulatory authorities and industry associationsassociations

Goal: harmonization and convergence Goal: harmonization and convergence of medical device regulatory practices of medical device regulatory practices

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GHTF: GHTF:

publishes harmonized documents on publishes harmonized documents on regulatory practices & definitions regulatory practices & definitions

for use by emerging economies and for use by emerging economies and developed nationsdeveloped nations

4 Study Groups focused on all phases 4 Study Groups focused on all phases of product life cycleof product life cycle

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GHTF:GHTF: Harmonization projects:Harmonization projects:

premarket regulatory practices,premarket regulatory practices,standardized premarket submission standardized premarket submission

format,format,labeling requirements labeling requirements data collectiondata collectionpost-market surveillance reporting post-market surveillance reporting

systems systems quality system requirementsquality system requirementsmedical device auditing processesmedical device auditing processes

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CDRH active in all Study Groups (SG); CDRH active in all Study Groups (SG); OIVD active in SG 1 OIVD active in SG 1

SG1: operational aspects of medical SG1: operational aspects of medical device regulation including IVD productsdevice regulation including IVD products

Current IVD harmonization projects:Current IVD harmonization projects: classification classification labelinglabeling IVD premarket conformity with IVD premarket conformity with

principles for safety and performance principles for safety and performance

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III. Process for FDA Recognition III. Process for FDA Recognition of Consensus Standardsof Consensus Standards

62 IVD Standards recognized by 62 IVD Standards recognized by CDRH (NCCLS)CDRH (NCCLS)

numerous non-IVD standards numerous non-IVD standards recognized recognized

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Mechanisms for proposing CDRH Mechanisms for proposing CDRH recognition of consensus standards:recognition of consensus standards:

1.1. Proposals by CDRH Specialty Task Proposals by CDRH Specialty Task Groups (STG) Groups (STG)

2.2. Proposals submitted by outside Proposals submitted by outside persons and considered by STGpersons and considered by STG

Publication in Federal RegisterPublication in Federal Register

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Specialty Task Groups:Specialty Task Groups:

Review previously recognized Review previously recognized Standards for relevanceStandards for relevance

Prepare list of priorities for new Prepare list of priorities for new projects projects

Propose the revision of existing Propose the revision of existing consensus documentsconsensus documents

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CONCLUSIONCONCLUSION

OIVD acknowledges the importance of OIVD acknowledges the importance of consensus standards:consensus standards:

impact on safety & effectivenessimpact on safety & effectivenessgreater premarket requirement greater premarket requirement

transparencytransparencyreview of submissions facilitatedreview of submissions facilitated

Active OIVD participation in development Active OIVD participation in development & recognition of STNDs& recognition of STNDs

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

1 consensus standards oivd workshop april 22-23, 2003 rockville md ginette y. michaud, m.d. oivd

Documents

role of consensus standards

consensus standards

recognized standards

minimum standards

requirements standards

fdas role

consensus documentsi

ivd premarket reviewconformity