Office of In Vitro Diagnostic Device Evaluation and Safety

Donald St.Pierre
Deputy Director for
New Device Evaluation

[Powerpoint]

RAPS 2003 Annual Conf. 10/22/03

OIVD UPDATE

• People
• TPLC Initiatives
• IVD Compliance
• IVD Premarket Review

I.  PEOPLE

• Where are they now?

-  Clara Sliva
-  Kaiser Aziz

• Who’s MDUFMA bought me?

II.  TPLC ACTIVITIES

• LabSun (7/9 labs trained)
• Patient Safety News (IVD Focus)
• OIVD Reviewing MDRs
• Webpage Updates
  -  OTC Database
  -  FDA Decision Summary
• CBER/CDRH Interactions

Ongoing TPLC Activities

• Continuous TPLC Training
• Outcomes – systemic review of literature
  -  lessons learned
• Info roll-in (process improvement)
  -  mtgs, contacts, listservs, MDRs, etc.
• Increase Communication/Visibility/Coordination
  -  NIH Research Steering Committee
  -  US Tag to ISO – prothrombin time

III.  IVD COMPLIANCE

• Talk first – all players involved
• Gather information
• Take action, if needed
  Step aside, if not
• Product experts on some inspections
• Investigating - can we say something good?

IV.  IVD PREMARKET REVIEW

• Steps to Mount Olympus
  -  Template-Based Review
  -  Template-Based Submissions
  -  Turbo 510(k)
• Up-front Collaborations/reduced review
  -  SARS IDE < 48 hours
  -  WNV Denovo < 1 week
• Customer Satisfaction Survey