1	OIVD Happy Birthday Premarket review – least burdensome, user fee goals, attention to critical path Compliance – December 02 Surveillance – November 03 Authority for CLIA – Fall 04
2	Current Organization Steven Gutman Don St. Pierre James Woods
3	Current Organization Jean Cooper (Cornelia Rooks) Robert Becker Sally Hojvat
4	Current Organization Joseph Hackett Sousan Altaie Mary Pastel
5	Current Organization Carol Benson Alberto Gutierrez Freddie Poole Josie Bautista Maria Chan
6	Premarket Review 620 submissions De novo sharp edged tool Continued use of pre-IDE (with earlier interactions) User fee time lines with some caveats
7	Compliance Technically more grounded – multitasking workers 120 recalls Variety of actions (visible and invisible) Risk based approach
8	Surveillance and Patient Safety MDRs – most valuable for negative signals LabSun – being expanded but return uncertain Not shortage of signals or opportunities to promote public health
9	CLIA 2000 classifications Waived – 8 % Moderate – 80% High – 12%
10	Imperfect Metrics Scorecards Improving Time lines are sharp Co-ordination of regulatory processes are strong (interdisciplinary decision making the rule) Serves IVD regulation well
11	Key Initiatives Web page – transparency Standardized review template Preliminary work on electronic review Increased leveraging
12	Future Goals Continue to re balance Better coordination of patient safety efforts Look for applications of critical path work Clarify or develop clearer regulatory positions
13	CLIA Issues Draft guidance Internal review GGPs Publication (early next year)
14	Draft Guidance AdvaMed constructions CLIAC recommendations (posted on web)
15	What’s Not New Simplicity Labeling – simple language, quick reference guide
16	What’s Gone Requirements for reference materials/methods Postmarket surveillance requirements Arbitrary QC requirements
17	What’s New Studies in hands of multi-tasking health care professionals over time (supplants lay users) Risk analysis (directs flex studies) Traceability (replace reference requirements) Data driven QC recommendations
18	Intended Use Studies Contours of multi-tasking studies uncertain
19	Risk Analysis ISO based documents – probably match existing QSRs
20	Traceability ISO based document Mathematically new
21	Data Based QC Should be logical extension of risk analysis
22	Performance Sufficiency of data Development of clinically relevant thresholds
23	Desired Outcome Broader menu of waived tests Strong basis in design and science for waiver Clear pathway Not going to be easy
24	MDRs IVD Round Table Product Re-enforced by evaluation of troponins Virtual working group Starting materials Re-visit Submit ideas/questions
25	ASRs/Home brews Last several months (four models in various stages of dress) Awkward product specific queries Issues of non-parity FDA commitment to work toward clarity
26	Informed Consent Working group Discussion of issue is both hierarchial and broad Multiple players within and outside CDRH
27	Informed Consent Clear work plan – unclear time line Guidance Enforcement discretion Regulation changes
28	Guidance Documents Son of Multiplex Joint Drug and Diagnostic Future documents in area of genomics/genetics
29	Turbo 510(k) First submission Three in pipeline E reviewer under development Try it, you might like it
30	FDA Has Involved Stakeholders Industry Professional Groups Government Opportunities for Collaboration, Creativity, and Innovation