Office of In Vitro Diagnostic Device Evaluation and Safety - from 11/17/02 to 11/17/03

Dr. Steve Gutman

[Powerpoint]

OIVD - 11/17/02

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

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

Chemistry Devices

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

Hematology/Immunology

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

Microbiology

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

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

FDA Planning

• Unresolved issues
• Legal authorities

FDA Work Plan

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

FDA Plan

• Internal documents developed
• Ongoing discussion
• Very complicated issues
• Central issue is risk assessment
• Challenging issue for SACGT
• Challenging issue for FDA
• Input expected from outside groups
• Input welcome

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

Statutory/Regulatory Limitations

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

Extensive Discussion

• Nuanced issues
• Complex issues
• FDA commitment to clarify

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

De Novo 510(k)s

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

FDA Revisit of ASRs

• Not focused on genetic testing alone
• Part of overall risk management initiatives without genetic exceptionalism
• Likely to take time
• Likely to be collaborative with other parts of HHS
• Likely to emphasize Commissioner’s goals of risk based and economic regulation
• Likely to emphasize Commissioner’s goal of consumerism

Alternative Review Models

• IVAT
• TPLC model
• IVAT – dockets open
• TPLC model – internal to Round Table
• Public Discussion -- minutes
• Common core issues
• Comport to public health mission
• Comport to law

IVAT Model

• Well established, classified analytes is the norm
• Clear intention is for more novel subsets
• How to delineate between investigational and clinical phase of use?
• How to classify without specific indications for use?
• How to address clinical validation?

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
• Challenge to refine and illuminate by example

Change in Review Practice

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

Template Based Review

• Posting review memos
• Home made template
• Work backwards
• Create turbo 510(k)
• Electronic format
• Paper format
• Review is 1040 and supporting information in schedule A, B, C etc.
• Submit turbo 510(k)
• Review fast
• Objectives similar although quantitatively different -- focused and fast reviews
• Allow for TPLC approach in or around model

Inherent Value of IVAT

• Model for establishing analytical performance
• Question at SACGHS

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

SARS

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

Informed Consent

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

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

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

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

OIVD Objectives

• Not unique
• Use Fee Goals
• TPLC
• Contribute to Commissioner’s Strategic Plan

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!