Office of In Vitro Diagnostic Device Evaluation and Safety Donald St.Pierre Deputy Director for New Device Evaluation 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

Premarket Activities (con’t) Process in reverse  Typical – application, then guidance  Atypical – guidance, then application Multiplex (Microarray) 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