FDA Perspective on IVD Regulation

1
FDA Perspective on IVD Regulation

• Alberto Gutierrez, Ph.D.
• Deputy Director for New Product Evaluation
• Office of In Vitro Diagnostics
• FDA

2
Organizational Change

• Steve Gutman Retired
• Don St.Pierre Acting Office Director

3
Organizational Change -- continued

• Liz Mansfield on Detail to the agency as Genomics
  Advisor to the Chief Scientist
• Sousan Altaie- Assistant Regional Director
  (Middle East Office), OIP
• Maria Chan Director of Division of Immunology
  and Hematology Devices
• Courtney Harper Acting Director of Division of
  Chemistry and Toxicology Devices

4
Organizational Change -- continued

• Bob Becker Chief Medical Officer
• A cadre of ten medical officers with specialties
  ranging from Infectious Disease, Pathology,
  Endocrinology and Rheumatology

5
Personalized Medicine Staff

• The hires to include
• PM director
• Statisticians
• Geneticists
• Microbiologists
• Biologists
• Chemists

6
Guidances

• IVDMIA under review
• CLIA Waiver
• Detection and Differentiation of Influenza
  Viruses
• Anti-Nuclear Antibody (ANA) Test System
• Migration Studies
• Nucleic Acid Amplification Assay for the
  Detection of Enterovirus RNA

7
Guidances continued

• CDER/CDRH joint Guidance Document draft published
  in 2007 on Antimicrobial Susceptibility Testing
  (AST) break points
• Novel use of FDAs standard recognition

8
Guidances

• ASR Questions and Answers September 15, 2008
  clarifying letter issued June 6, 2008
• Manufacturers provided plans to come into
  compliance
• Met with laboratory representatives including
  representatives from Pan American Society for
  Clinical Virology (PASCV) to address impact on
  laboratories

9
Notable New Clearances

• rRT-PCR Flu Panel test a CDC Test to Detect
  Human Influenza

10
Emergency Use Authorizations

• CDCs rRT-PCR Swine Flu Panel
• CDCs rRT-PCR Flu Panel (NPS,NS,TS,NPS/TS,NA) and
  Viral Culture

11
Notable Panel Meetings

• Advisory panel meeting on Fujirebio Diagnostics
  Inc. HE4 Enzyme Immunoassay and Risk of Ovarian
  Malignancy AlgorithmTM (ROMATM)
• ODAC panel meeting on K-RAS testing

12
Postmarket Actions

• Warning letter to LabCorp for OvaSure
• Quest Subsidiary, Nichols Institute Diagnostics,
  pleaded guilty to felony misbranding 302
  million settlement

13
Critical Path Programs

• Genomics interactions with NCI including EDRN,
  SPORE, PACCT, BRN and with CDC (EGGAP)
• Artificial pancreas
• Nanotechnology

14
Waiver of CBC/Differential Cell Count

• FDA panel meeting to discuss CBC/Differential
  Cell Count waiver issue
• Presented to CLIAC

15
Regulation of Laboratory Developed Test

• Wide variety of tests
• Common practice in laboratories
• Medical devices
• FDA enforcement discretion
• Recognition of CLIAs role

16
Regulation of Laboratory Developed Test

• Industry - Parity between IVDs and LDTs
• Consumer advocates - more comprehensive
  regulatory assurances
• Commercial Laboratories predictability
• Congress concerned with issues
• Kennedy, Obama bills
• GAO DTC testing report

17
Regulation of Laboratory Developed Test

• WLF petition under review
• Genentech Petition under review
• Several comments con and pro
• Problem is clear
• No easy answers