Regulatory Decision Regulatory Decision MakingMaking

D. Kathleen Wright, Reviewer D. Kathleen Wright, Reviewer Division of Microbiology Division of Microbiology

Office of In Vitro Diagnostic Device Office of In Vitro Diagnostic Device Evaluation & Safety (Evaluation & Safety (OIVDOIVD))

Food and Drug AdministrationFood and Drug Administration

Clinical Virology Symposium Clinical Virology Symposium

April 27, 2003April 27, 2003

Risk Based Risk Based

ClassificationClassification

Class IClass I

Most Most exemptexempt from pre-mkt. from pre-mkt. notification [510(k)]notification [510(k)]

ReservedReserved: : EBV, TBEBV, TB Limitation to exemptionLimitation to exemption::

IgM AssaysIgM Assays Life threatening diseasesLife threatening diseases

Class IIClass II

Reasonable assurance of Reasonable assurance of safety and effectiveness safety and effectiveness

can can be obtained by be obtained by applying applying "special controls" "special controls"

Regulatory OptionsRegulatory OptionsClass I & IIClass I & II

TraditionalTraditional 510(k) 510(k) AbbreviatedAbbreviated 510(k) w/std. 510(k) w/std. SpecialSpecial 510(k)-Data 510(k)-Data

Summary Summary 3rd3rd Party review Party review De novoDe novo::

Automatic ClassificationAutomatic Classification

Class IIIClass III Present a potential, Present a potential,

unreasonable risk of illness unreasonable risk of illness or or injury.injury.

No PredicateNo Predicate PMAPMA (Pre-market approval) (Pre-market approval) ModularModular PMA PMA

CLIA CategoriesCLIA Categories

0

200

400

600

800

1000

1200

1400

1600

1800

2000

FY1999 FY2000 FY2001 FY2002

WaivedModerateHigh

Waiver CriteriaWaiver Criteria Accuracy and precisionAccuracy and precision

Utilized with an FDA cleared Utilized with an FDA cleared assayassay

Field studies @ 3 sites w/20 Field studies @ 3 sites w/20 participants/siteparticipants/site

Statistical evaluation @ FDAStatistical evaluation @ FDA

SimplicitySimplicity Specimen unprocessed Specimen unprocessed No intervention during studyNo intervention during study Fail safe mechanism Fail safe mechanism Step by step instructionsStep by step instructions

CHANGESCHANGES Re-think regulatory processRe-think regulatory process

ProtectProtect public health in a less public health in a less burdensome mannerburdensome manner

PostPost-market surveillance-market surveillance

GMP enforcementGMP enforcement

Streamline premarket reviewsStreamline premarket reviews

More interaction-More interaction-stakeholders stakeholders

RESULTRESULT New OfficeNew Office - IVDs - IVDs

One stop shoppingOne stop shopping

CombineCombine – – IVD review w/IVD review w/

Compliance & SurveillanceCompliance & Surveillance

Overriding ThemesOverriding Themes

Total Product Life Cycle (Total Product Life Cycle (TPLCTPLC))

Shift Shift directiondirection - premarket to postmarket - premarket to postmarket

GlobalGlobal market regulatory harmonization market regulatory harmonization

LeastLeast burdensome burdensome

Functional ComponentsFunctional Components PremarketPremarket

Streamline/standardize Streamline/standardize review review

Pre-IDE ProtocolPre-IDE Protocol Shift labeling toward Shift labeling toward educational/informational educational/informational

PostmarketPostmarket Active surveillance & outreachActive surveillance & outreach IVD IVD webpage webpage

httphttp://www.fda.gov/cdrh/oivd://www.fda.gov/cdrh/oivd

Continued Office Continued Office ActivitiesActivities

BioterrorismBioterrorism Emerging InfectionsEmerging Infections Professional Round-TableProfessional Round-Table IVD Round-TableIVD Round-Table

SummarySummarySummarySummaryPre-marketPre-market

Premarket Review –Premarket Review – Design, Performance & LabelingDesign, Performance & Labeling

Guidance documents, StandardsGuidance documents, Standards Investigational device exemptions (Investigational device exemptions (Pre-Pre-

IDEIDE)) GMP’sGMP’s & Quality Systems & Quality Systems

Post-marketPost-market Medical Device Reporting (Medical Device Reporting (MDRMDR)) Safety AlertsSafety Alerts: Advisories, technical : Advisories, technical

reports, recallsreports, recalls