# Presentation: 316701

## OIVD Highlights (AdvaMed, May 2005)

- Donald St.Pierre
- Deputy Director for New
-   Device Evaluation
- HHS/FDA/CDRH/OIVD

## Office of In Vitro Diagnostics(Born – Nov. 2002)

- One organizational unit to regulate all IVDs through their Total Product Life Cycle using Knowledge Management
- One stop shopping
- Regulation from common technical base w/ a goal to better connect premarket review, compliance/enforcement actions, and postmarket monitoring

## Office of In Vitro Diagnostics

- 3 divisions support all tech. decision-making
- Compliance in matrix form
- MDR analysts are embedded in divisions
- Cross hires with compliance, postmarketing and research groups
- Total regulatory staff now about 85 FTE
- 	(25 FTE increase since creation)

## Multi-Tasking Work Force – Small, But Effective

- Premarket Review – 650/ year
- Denovo (Since FY03 - OIVD(13), ODE(5))
- Compliance Actions – 150/ year (range from recalls to enforcement letters to seizures)
- MDR Surveillance – 10,000 reports/ year
- CLIA – 2000 categorizations/ year
- _Match premarket & postmarket performance_

## Customer Perception Survey(Top 9 Responses out of 114 Responses)

- 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

## Uniquely IVD

- Patient Safety Team
- Problem Identification and Resolution
- Capture Incoming Signals (AE database)* *_*New!*_
- CBER/CDER interactions
- Enhanced Coordination (pre and postmarket)
- Pre-IDE survey
- Assess the value
- Turbo 510(k)

## Uniquely IVD Compliance/Enforcement

- QSR Inspections
- Risk-based inspection planning
- Inspection Training for product experts (more likely to see OIVD person)
- Field interactions on the rise (visit DO if we can)
- BiMo Inspections
- Early premarket identification and ownership
- Result – more use of AIP

## Uniquely IVDthe OIVD Web Page

- Primary goal is transparency
**Standardized decision summary posted**
- Public compliance actions posted
- Laboratory safety information posted
- _www.fda.gov/cdrh/oivd_

## 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)

## Guidances Getting Close

- Pharmacogenetics/Genetic Tests (draft)
- Nucleic Acid Amplification Tests (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)

## 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)
- Critical Path opportunities – not just genomics, but biomarkers in general

## Big & Awkward Policy Issues

- ASRs/Home brews
- Ongoing compliance evaluation, issues, and actions
- Issues of non-parity and non-congruity between CLIA and FDA processes unresolved
- Informed Consent
- Increased appreciation of non-congruence between HHS (common) rule and FDA requirements
- High level HHS interest in harmonization

## Continuing Goals

- Continue to re-balance programs to reflect Total Product Life Cycle regulation
- Better coordination of patient safety efforts
- Clarify or develop clearer regulatory positions

## Wisely use existing regulatory tool box
Ensure review transparency & clear labeling
Meet the letter and spirit of the law to have a “least burdensome” review threshold
Proactively partner in translational phase of product development

- Wisely use existing regulatory tool box
- Ensure review transparency & clear labeling
- Meet the letter and spirit of the law to have a “least burdensome” review threshold
- Proactively partner in translational phase of product development

## Unique product line
Unique organizational program 
Unique policy challenges, BUT we’ve got the
Right resources
Right regulatory support
Right communication
Potential for success or interesting failures

- Unique product line
- Unique organizational program
- Unique policy challenges, BUT we’ve got the
- Right resources
- Right regulatory support
- Right communication
- Potential for success or interesting failures

## Passionate cadre of innovative scientists
An industry with imagination, energy, and a healthy competitive spirit
Clear public health mission and vision
Public commitment to good science

- Passionate cadre of innovative scientists
- An industry with imagination, energy, and a healthy competitive spirit
- Clear public health mission and vision
- Public commitment to good science

## Monitor the OIVD webpage for the latest on IVDswww.fda.gov/cdrh/oivdThank You and Have a Great Meeting