1	Office of In Vitro Diagnostic Device Evaluation and Safety Donald St.Pierre Deputy Director for New Device Evaluation IVD Roundtable Update, May 2005
2	OIVD Office Summary Now 2+ years old Newest and smallest organizational unit TPLC does actually work Better pre and postmarket coordination/decision-making Better Compliance/Enforcement focus
3	OIVD Personnel Summary November 2002 – 60 FTEs Today – 85 FTEs Jean Cooper – on detail to FDA Exec Sec Carol Benson acting Looking Internally to temp. fill Team Leader CLIA questions to Carol Benson Most new staff starting independent reviews FY05 performance very encouraging
4	Completed Perception Survey 26% pleased with process 18% no comments 14% lack of consistency (cross-division mtg) 14% problems with communication (reminders) 10% guidance doc. need updating (in-process) 8% web-site needs improving (recent facelift) 4% not least burdensome (not bad) 4% user fees excessive 4% reviews not timely
5	Surveys Underway Pre-IDEs Assess perception Assess market submission quality Assess impact on timeliness
6	Premarket Stuff
7	Original PMA Approvals
8	PMA Supplement Approvals
9	510(k) Receipts
10	510(k) Review Stats
11	Other OIVD Documents
12	CLIA Workload
13	Denovo OIVD has this tamed Since OIVD created (13 vs 5 for ODE) Broad but not over-reaching view of risk Turnaround from 510(k) receipt to denovo order (30 – 200 days, 110 days on ave.)
14	Guidances Published Final Guidances Published in FY04/05: 10 Special Control Guidances Replacement Reagent Policy Draft Guidances Published in FY04/05: Drugs of Abuse Screening tests Hepatitis A Virus (companion document to proposed down-classification of HAV) (7 guidances FY02/03 vs. 13 (& counting) FY04/05)
15	Guidances Getting Close Pharmacogenetics/Genetic Tests (draft) NAAT (draft) IVD Studies (draft) 5 SCGD (HAV (final), HSV (draft), 3 Denovos) CLIA Waiver (draft) C-reactive protein (draft) OTC Ovulation Predication (draft) Portable Glucose Monitoring (draft) Glucose MDR Guidance (draft)
16	Postmarket Stuff
17	Postmarket Surveillance Patient Safety Team Adverse Events Database (New) Link all incoming signals User interactive Allows customized data analysis (e.g., by event, by manufacturer) MDR Reviews Overuse of “OTHER” event type
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19	Postmarket Surveillance (con’t) Condition of Approval Studies Only one to date More Likely if: Not appropriate to label accordingly Important question still needs answering Better pre-/post-marketing balance Suggestions to create a better balance?
20	II. Compliance/Enforcement Inspections Risk-based inspection planning Inspection Cadre (more likely to see OIVD person) Staff taking Inspection Training Field interactions on the rise (visit DO when we can) OIVD – not a work-around to the field
21	Compliance (con’t) Premarket Application Review 30-day notices Mfg. site changes Annual Reports (pending) Bioresearch Monitoring (BiMo) More focused Applications on AIP continue (BAD!) Registration & Listing More synergy
22	Time-consuming Stuff
23	ASRs Arabian bazaar of activity Pseudo-kits Marketing of microarrays and RUOs inappropriately FDA slow but steady responses
24	Informed Consent Bottom line Lots of behind-the-scenes activities Very little completed OIVD and industry on the same page Working hard to get some interim solution
25	Genomics Hot button item FDA working closely with CDER Recent collaborative concept paper (precedent setting in scope of work and collaboration) Recent collaborative workshop (DIA)
26	Critical Path Biomarkers is the focus Good mechanism to bring IVD’s to the table Have FDA’s ear Have CDER and PharMA’s ear Have OIVD insider
27	Monitor the OIVD webpage for the latest on IVDs www.fda.gov/cdrh/oivd Comments are Welcome