1	OIVD – Update on a Work in Progress Steven Gutman, M.D.
2	Office of In Vitro Diagnostic Device Evaluation and Safety Newest Smallest Longest name
3	Office of In Vitro Diagnostic Device Evaluation and Safety Three years old TPLC culture Regulatory transparency Laboratory for learning
4	Office of In Vitro Diagnostic Device Evaluation and Safety Does embody TPLC Does encourage knowledge management Does work very well for IVDs
5	Face of FDA Dr. Andrew Von Eschenbach, Acting Commissioner; Commissioner Designate
6	Face of FDA Dr. Scott Gottlieb, Deputy for Policy and Medical Affairs Dr. Janet Woodcock, Deputy for Operations Dr. Murray Lumpkin, Deputy for International Affairs Sheldon Bradshaw, Head, Chief Counsel
7	FACE of CDRH Dr. Dan Schultz, Center Director Linda Kahan, Deputy Director Lillian Gill, Associate Director for Science
8	Face of OIVD Web page www.fda.gov/cdrh/oivd Phone: 240-276-0484 Fax: 240-276-0664
9	Face of OIVD Dr. Steven Gutman, Director Don St. Pierre, Deputy Director James Woods, Deputy Director Dr. Joseph Hackett, Associate Director Dr. Sousan Altaie, Scientific Policy Advisor
10	Face of OIVD -- Microbiology Dr. Sally Hojvat, Director Freddie Poole, Associate Director
11	Face of OIVD – Immunology and Hematology Dr. Robert Becker, Director Josie Bautista, Associate Director Dr. Maria Chan, Associate Director
12	Face of OIVD – Chemistry and Toxicology Dr. Alberto Gutierrez, Director Carol Benson, Associate Director Dr. Courtney Harper, Associate Director
13	Major Submissions Received FY 01 - FY 05
14	Average 510(k) Review Time for Decision Cohort
15	Average Review Time for PMA Decision Cohort Approvals
16	Average Pre-IDE Review Time for Decision Cohort
17	Quality of Work Changing More combination products More molecular diagnostics More computer driven products More point of care products
18	MDUFMA Increased work force Increased work expertise Improved training Improved IT infrastructure
19	Critical Path Broad initiative Biomarkers mentioned twice Biomarkers for diagnostic purposes Biomarkers for drug discovery
20	Critical Path Inter-oncology task force Pharmacogenomics River runs deep – cancer plus diabetes, infectious disease testing, coagulation, other
21	Pharmacogentic tests and Genetic Tests for Heritable Markers Draft Guidance for Industry and FDA staff – February 2006 -- 90 day comment period http://www.fda.gov/cdrh/oivd/guidance/1549.html
22	Ongoing Series of Documents http://www.fda.gov/cder/guidance/5900dft.pdf --Voluntary Genomic Data Submissions http://www.fda.gov/cder/genomics/pharmacoconceptfn.pdf --Concept paper on co-development http://www.fda.gov/cdrh/osb/guidance/1428.html -- Statistical methods for test evaluation
23	Two Semi-Formal Processes Voluntary genomic data submissions Pre-IDEs (protocol reviews) Pipeline is full; time line unpredictable
24	Interest in Identifying New Stakeholders Internal blitz – CDER External blitz – PHARMA, BIO Multi-level interactions with NIH Interest in niche round table
25	Seasoned Regulatory Toolbox Pre-IDE Expedited reviews Real time reviews De novo classifications
26	Pre-IDEs Pop quiz Questions ahead Discuss answers
27	Pre-IDEs Question questions Increase certainty of review path Ensure quality of submission
28	Expedited Review Blue book memo Break in line Faster answer but No money without check
29	Real Time Review Nike slogan Borrowed from niche PMA supplement Broadly applied internally Sometimes applied externally
30	De Novo Classification Low risk devices Broad view of risk control Not ubiquitous
31	Review Successes Cystic Fibrosis Test – 101 review days West Nile Virus – 17 review days Influenza Test – 14 review days UGT1A1 – 9 review days
32	Preeminent Guidances Informed consent guidance ASR guidance
33	ASR Challenge In House (Home Brew) Tests – continue to be popular alternative Colorful market place with confusion Parity problem
34	ASR Challenge Guidance to clarify boundaries of ASR and home brew Stick (encourage conformance) Carrot (ensure least burdensome route to market)
35	Obstacles to Critical Path Lewin Report and need for value based pricing Increasing understanding that adoption and payment require more then FDA clearance Health care costs growing – need for better economic as well as scientific case for IVDs
36	Turbo 510(k) Based on review template Transparent work process Standardized work process Focused work process
37	Electronic Revolution Objective to move toward paperless work Turbo 510(k)s E consults E MDRs E rooms for common work interests
38	Commitment to Change Already multi-tasking is rule Shift from premarket to pan-market focus Not quick and easy; slow and steady
39	Influenza Avian flu – prime time Radar screen last fall Shows TPLC in action
40	Influenza Unsubstantiated claims Compliance action Premarket reviews Lab safety tip Guidance on labeling and claims De novo clearance
41	FDA Dual Mission Promote public health Prevent public health Tension between goals
42	FDA Dual Mission Good news – amazing innovative products and science Better news – experienced work crew with excellent scientific and regulatory tools Regulatory focus