1. 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

2. Risk Based Classification

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

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

5. 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

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

7. CLIA Categories

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

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

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

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

12. Functional Components  Premarket  Streamline/standardize review  Pre-IDE Protocol  Shift labeling toward educational/informational  Postmarket  Active surveillance & outreach  IVD webpage http ://www.fda.gov/cdrh/oivd

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

14. 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