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2	Challenges & Opportunities Predictability Transparency Consistency What’s Ahead
3	1) Predictability Guidances Standards Presentations Pre-IDEs Review Performance
4	Guidance
5	Guidance Philosophy Informed Consent - Enforcement discretion is good BUT patient protections must be in place. CLIA waiver - 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. Special Control Guidances - support the denovo process
6	Standards ~50% of Staff involved 98 recognized standards Includes national & international, but most active in CLSI
7	Presentations 90% management staff participation IVD Roundtable 510(k) Workshop – April 18-19, 2006 eConference: Educating IVD Manufacturers – June 13, 2006 CBER / OIVD Migration Studies Workshop – June, 2006
8	Pre-IDEs A free consultative service by the review staff at the FDA A non binding agreement between FDA & sponsor FDA hopes it: ?Results in a well prepared submission ?Results in a shortened review time ?Results in saving research $$$ Or maybe it is just peace of mind
9	Performance Expectations 510(k) – around 60 days Specials around 30 days PMA/P-T PMA/S – around 100 days PMA/S –around 100 days Real-Time PMA/S – around 60 days 30-day notices – around 25 days Pre-IDEs – around 60 days Depends a lot on you – not just FDA
10	2) Transparency Decision Summaries CeSUB (a.k.a - Turbo 510(k)) Website Customer Perception Survey
11	510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY Contains 510(k) Number Purpose for Submission Measurand Type of Test Applicant Proprietary and Established Names Regulatory Information Intended Use Device Description Substantial Equivalence Information Standard/Guidance Document Test Principle Performance Characteristics Other Supportive Instrument Performance Proposed Labeling Conclusion
12	Turbo 510(k) Capabilities: Standardized submission templates for IVDs Standardize review memo format Integrates electronic submission and an electronic review process Reduce costs associated with paper (including scanning) and potential errors associated with re-keying Enhance data integrity from mfg through to CDRH
13	Turbo 510(k) Submissions Overview Timeline May 2004 – Pilot begun September 2004 – First submission October 2005 – Program open to all IVD manufacturers Statistics 50 510ks received as of May 25, 2006 16 different sponsors; good review times (40 days FDA, 10 days MFG)
14	OIVD Website http://www.fda.gov/cdrh/oivd/index.html Patient Safety Communications Lab Safety Tips Industry Communications Warning letters Other IVD-related news Please provide suggestions for improvement
15	Premarket Customer Perception Survey Top Nine Responses for OIVD out of 114 Responses 26% pleased with process 18% none 14% lack of consistency 14% problems with communication 10% guidance documents need updating 8% website needs improving 4% FDA is not least burdensome in approach 4% user fees excessive 4% reviews not timely
16	3) Consistency New Reviewers Across Reviewers/Divisions Postmarket Decision Making – An OIVD Work Audit
17	New Reviewer Training Assign Mentor Co-review With Senior Reviewer CDRH Reviewer Training Courses Staff College Web-based Courses Internal New Reviewer Training given by Staff Member
18	Across the Office Management meetings All-hands meetings Focus groups Cross-Cutting Teams Genomics Patient Safety Issue Resolution Policies Replacement reagents Migration Studies
19	Pre/Postmarket OIVD Work Audit Jan 20 to Feb 28, 2006 55 pre/post market meetings HHE’s – 17 PMA issues – 14 (5 scientific; 9 BiMo) Compliance letters – 7 MDR reports – 7 Other – labeling, import issues -- 10
20	Organizational Ownership -- subject specific work Flu problem – Roxanne Shively, Claudia Gaffey Women’s health problem – Veronica Calvin Problem with fungi or parasites – Freddie Poole Glucose problem – Pat Bernhardt POC problem – Arleen Pinkos, Carol Benson Coagulation problems – Josie Bautista
21	Organizational Ownership -- subject specific work TDM problem – Avis Danishefsky Instrument problem – Jim Callaghan Software algorithm problem – Mary Pastel Cytology problem – Louise Magruder, Max Robinowitz Genetics problem – Joe Hackett, Bob Becker, Maria Chan Etc.
22	4) Where are we & What’s ahead Changing work MDUFMA Focus issues In the works
23	Type of Work Changing More combination products More molecular diagnostics More computer driven products More point of care products
24	MDUFMA Increased work force Increased work expertise Improved training Improved IT infrastructure
25	MDUFMA enables: Time for HAV downclassification Time for HSV proposed downclassification Time for denovo applications Time for Informed Consent guidance Time for CLIA Waiver guidance Time to develop Turbo 510(k) Time for ASR guidance (pending) Time for Migration Studies (pending)
26	Focus Issues ASRs and Home Brew Focus Critical Path - Biomarkers Drug/Device Co-development Focus Combination Products Focus Genomics Focus Bioterrorism Focus More Turbo 510(k) Focus More Postmarket Focus (including QSR, visiting booths, LabNet)
27	FY06 & 07 Guidances (in draft) Final Guidance CLIA Waiver Migration Studies ASR Q & A TDM Guidance Glucose MDR And others
28	"Thank You" Thank You Don St.Pierre don.st.pierre@fda.hhs.gov Ph. (240) 276-0450 Fax (240) 276-0664 OIVD Web Site: http://www.fda.gov/cdrh/oivd/index.html