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21	Pharmacogentic tests and Genetic Tests for Heritable Markers Draft Guidance for Industry and FDA staff – February 2006 -- 90 day comment period http://www.fda.gov/cdrh/oivd/guidance/1549.html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	Two Preeminent Guidances Waiver guidance Informed consent guidance
33	Waiver Guidance Intellectual framework from industry Niceties from CLIAC Details from FDA
34	Waiver Guidance Forty four comments All over map Many constructive Some still being provided
35	Waiver Guidance FDA guiding philosophy Access to tests is good BUT Concerns over degradation in performance are real and credible methods need to be applied to design and demonstration that design works
36	Informed Consent Non-congruence with Common Rule used by NIH FDA law requires informed consent for human subject FDA regulation defines sample as human subject Law is air tight Ignorance is not bliss
37	Informed Consent Enforcement discretion Allow use of -- routinely collected -- leftover -- de-linked samples
38	Informed Consent Need for regulation fix Paperwork statement presages guidance (January 2006)
39	ASR Challenge In House (Home Brew) Tests – continue to be popular alternative Colorful market place with confusion Parity problem
40	ASR Challenge Highest priority remaining guidance to clarify boundaries of ASR and home brew Stick (encourage conformance) Carrot (ensure least burdensome route to market)
41	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
42	Turbo 510(k) Based on review template Transparent work process Standardized work process Focused work process
43	Electronic Revolution Objective to move toward paperless work Turbo 510(k)s E consults E MDRs E rooms for common work interests
44	Commitment to Change Already multi-tasking is rule Shift from premarket to pan-market focus Not quick and easy; slow and steady
45	Commitment to Change Limits in resources Limitations of law Limitations of science
46	Complex Patient Safety Program Patient safety team New data bases Assessment of connections
47	Complex Patient Safety Program Part of Center transformational team but with unique opportunities Self-study and evaluation of what works
48	Work in Progress Unfinished business Opportunities for refinement Science of evaluation is undergoing a revolution
49	Work in Progress Literature replete with methods papers Increased standards including ISO work FDA guidances
50	FDA Dual Mission Promote public health Prevent public health Tension between goals
51	FDA Dual Mission Good news – amazing innovative products and science Better news – experienced work crew with excellent scientific and regulatory tools Regulatory focus