Regulatory Decision Making D. Kathleen Wright, Reviewer Division of Microbiology Office of In Vitro Diagnostic Device Evaluation & Safety ( OIVD ) Food.

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Presentation transcript:

Regulatory Decision Making D. Kathleen Wright, Reviewer Division of Microbiology Office of In Vitro Diagnostic Device Evaluation & Safety ( OIVD ) Food and Drug Administration Clinical Virology Symposium April 27, 2003

Risk Based Classification

Class I  Most exempt from pre-mkt. notification [510(k)]  Reserved: EBV, TB  Limitation to exemption :  IgM Assays  Life threatening diseases

Class II  Reasonable assurance of safety and effectiveness can be obtained by applying "special controls"

Regulatory Options Class I & II  Traditional 510(k)  Abbreviated 510(k) w/std.  Special 510(k)-Data Summary  3rd Party review  De novo: Automatic Classification

Class III  Present a potential, unreasonable risk of illness or injury.  No Predicate  PMA (Pre-market approval)  Modular PMA

CLIA Categories

Waiver Criteria  Accuracy and precision  Utilized with an FDA cleared assay  Field 3 sites w/20 participants/site  Statistical FDA  Simplicity  Specimen unprocessed  No intervention during study  Fail safe mechanism  Step by step instructions

CHANGES  Re-think regulatory process  Protect public health in a less burdensome manner  Post-market surveillance  GMP enforcement  Streamline premarket reviews  More interaction-stakeholders

RESULT New Office - IVDs  One stop shopping  Combine – IVD review w/ Compliance & Surveillance

Overriding Themes  Total Product Life Cycle (TPLC)  Shift direction - premarket to postmarket  Global market regulatory harmonization  Least burdensome

Functional Components  Premarket  Streamline/standardize review  Pre-IDE Protocol  Shift labeling toward educational/informational  Postmarket  Active surveillance & outreach  IVD webpage http ://

Continued Office Activities  Bioterrorism  Emerging Infections  Professional Round-Table  IVD Round-Table

SummarySummary Pre-market  Premarket Review – Design, Performance & Labeling  Guidance documents, Standards  Investigational device exemptions (Pre-IDE)  GMP’s & Quality Systems Post-market  Medical Device Reporting (MDR)  Safety Alerts: Advisories, technical reports, recalls