OIVD - 11/17/02

1
OIVD - 11/17/02

• Organization in place
• Educational programs in place
• Transfer of compliance
• Transfer of surveillance
• Learning by experience
• Charrette to ensure focus

2
Office Management

• Steve Gutman, M.D, Director
• Don St. Pierre, Deputy Director
• James Woods, Deputy Director
• Joseph Hackett, Ph.D., Associate Director
• Sousan Altaie, Ph.D., Scientific Policy Advisor

3
Chemistry Devices

• Jean Cooper, DVM, Director
• Carol Benson, Team Leader, Chemistry
• Alberto Gutierrez, Ph.D., Team Leader, Toxicology

4
Hematology/Immunology

• Tim OLeary, Ph.D., M.D., Director
• Josie Bautista, Team Leader, Hematology
• Maria Chan, Ph.D., Team Leader, Immunology

5
Microbiology

• Sally Hojvat, Ph.D., Director
• Freddie Poole, Deputy Director

6
SACGT Recommendations

• Challenging
• Broad menu for HHS with suggestions for
  enhancements in oversight by CMS, FDA, and CDC
• FDA charged with regulating new genetic tests

7
SACGT Recommendations

• Risk based
• Non-chilling
• Informed by professional societies

8
FDA Planning

• Unresolved issues
• Legal authorities

9
FDA Work Plan

• FDA has asserted authority over ASRs
• FDA is considering possibility of incremental
  changes

10
FDA Plan

• Internal documents developed
• Ongoing discussion
• Very complicated issues

11
FDA Plan

• Central issue is risk assessment
• Challenging issue for SACGT
• Challenging issue for FDA
• Input expected from outside groups
• Input welcome

12
Microarray/Other Technology

• Under statute by default new device is class III
• ASR is one type of new device
• Microarray may not be class I exempt if it falls
  outside description of class I

13
Statutory/Regulatory Limitations

• All devices have limitations to exemption
• Even microarrays that might satisfy description
  of ASR classifications may trip limitations

14
Extensive Discussion

• Nuanced issues
• Complex issues
• FDA commitment to clarify

15
If Premarket Notification Submission Is Required

• If a given microarray cannot be found SE to a
  legally marketed predicate ASR, it becomes class
  III
• Devices remain class III unless given a new
  classification by formal classification or new
  statutory option of de novo classification

16
De Novo 510(k)s

• Flexible option when appropriate
• Fast option when needed
• Broad option -- TDM Round Table

17
FDA Revisit of ASRs

• Not focused on genetic testing alone
• Part of overall risk management initiatives
  without genetic exceptionalism
• Likely to take time

18
FDA Revisit of ASRs

• Likely to be collaborative with other parts of
  HHS
• Likely to emphasize Commissioners goals of risk
  based and economic regulation
• Likely to emphasize Commissioners goal of
  consumerism

19
Alternative Review Models

• IVAT
• TPLC model

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Alternative Review Models

• IVAT dockets open
• TPLC model internal to Round Table
• Public Discussion -- minutes

21
Alternative Review Models

• Common core issues
• Comport to public health mission
• Comport to law

22
IVAT Model

• Well established, classified analytes is the norm
• Clear intention is for more novel subsets

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IVAT Model

• How to delineate between investigational and
  clinical phase of use?
• How to classify without specific indications for
  use?
• How to address clinical validation?

24
TPLC Model

• Lack of understanding of how model relates to FDA
  determination that new device is as safe and
  effective as predicate threshold addressed
• Concerns over certification process for quality
  systems
• Link between hazard analysis and SE not clear

25
TPLC Model

• Challenge to refine and illuminate by example

26
Change in Review Practice

• More incremental
• Based on current tools
• Not challenge regulations or statutes

27
Template Based Review

• Posting review memos
• Home made template
• Work backwards
• Create turbo 510(k)

28
Template Based Review

• Electronic format
• Paper format
• Review is 1040 and supporting information in
  schedule A, B, C etc.
• Submit turbo 510(k)
• Review fast

29
Template Based Review

• Objectives similar although quantitatively
  different -- focused and fast reviews
• Allow for TPLC approach in or around model

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Inherent Value of IVAT

• Model for establishing analytical performance
• Question at SACGHS

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Value of TPLC model

• Need to refine regulation in the context of a
  bigger picture than premarket review
• Need to consider risk management in a more
  concrete manner
• Need to consider conformance between QSRs and ISO
  approaches

32
SARS

• CDC IDE
• De novo West Nile
• SARS workshop
• SARS guidance on hold sort through complex
  issues
• Working with companies individually -- build
  experience needed

33
Informed Consent

• No OIVD level activity in this area
• Does industry plan to weigh in
• Changing environment
• Current recommendations -- talk to your IRB

34
Compliance

• Learning phase
• First choice to work with companies informally to
  identify and correct problems
• Second choice is to use regulatory tools
• Some cases second choice comes first by
  requirement or default

35
Issue of Patient Safety

• Profound cultural change
• Commissioner initiatives for risk management,
  economic regulation, and consumerism
• CDC and quality institute
• Seeking innovative programming
• May be gold in these hills

36
General Compliance Themes

• Coordinated work groups
• Use of OIVD web page to communicate issues
• Better use of existing signals
• Collaborating with industry to heighten safe use
  of laboratory devices

37
OIVD Objectives

• Not unique
• Use Fee Goals
• TPLC
• Contribute to Commissioners Strategic Plan

38
OIVD -- 11/17/03

• Organization in transition
• Moving toward different regulatory model
• Not always smooth
• Not always fast and direct
• Challenging, dynamic, and entrepreneurial
  industry that always makes this work important
  and fun!