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 Current Issues/Hot Topics

• CLIA Activities
• Premarket Activities
• Postmarket Activities

I.  CLIA

• Status quo, but
• DHHS looking into delegation of authority

II.  Premarket Activities

• Replacement Reagent
  -  Update & remove need for Add-to file
• Bundling
  -  Continuing smoothly
  -  Note: class I + class II = class II
• Not Bundling, but processing change
  -  e.g., HBV, PSA
• Expedited – Denovo & FDA Identified
• Process in reverse
  -  Typical – application, then guidance
  -  Atypical – guidance, then application
       o  Multiplex (Microarray)
       o  Rapamycin
• BiMo Guidance
  -  Refocus efforts
  -  Informed consent/patient samples
• New 510(k) Review Models
  -  Too early to comment

III.  Postmarket Activities

• Symbols
  -  Okay in 510(k)s – if no impact on SE decision
  -  Not okay in PMAs yet, but not taking action
• Electronic Labeling
  -  Okay for IVDs?
       If so, then good
       If not, then we’ll let you know so you can fight

Monitor the OIVD webpage for the latest on IVDs

www.fda.gov/cdrh/oivd