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

SACGT Recommendations

• 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

FDA Plan

• 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

FDA Revisit of ASRs

• 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

Alternative Review Models

• IVAT – dockets open

• TPLC model – internal to Round Table

• Public Discussion -- minutes

Alternative Review Models

• 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

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?

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

TPLC Model

• 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)

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

Template Based Review

• 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!