OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer...
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Transcript of OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer...
![Page 1: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/1.jpg)
OIVD - 11/17/02
• Organization in place
• Educational programs in place
• Transfer of compliance
• Transfer of surveillance
• Learning by experience
• Charrette to ensure focus
![Page 2: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/2.jpg)
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
![Page 3: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/3.jpg)
Chemistry Devices
• Jean Cooper, DVM, Director
• Carol Benson, Team Leader, Chemistry
• Alberto Gutierrez, Ph.D., Team Leader, Toxicology
![Page 4: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/4.jpg)
Hematology/Immunology
• Tim O’Leary, Ph.D., M.D., Director
• Josie Bautista, Team Leader, Hematology
• Maria Chan, Ph.D., Team Leader, Immunology
![Page 5: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/5.jpg)
Microbiology
• Sally Hojvat, Ph.D., Director
• Freddie Poole, Deputy Director
![Page 6: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/6.jpg)
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
![Page 7: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/7.jpg)
SACGT Recommendations
• Risk based
• Non-chilling
• Informed by professional societies
![Page 8: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/8.jpg)
FDA Planning
• Unresolved issues
• Legal authorities
![Page 9: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/9.jpg)
FDA Work Plan
• FDA has asserted authority over ASRs
• FDA is considering possibility of incremental changes
![Page 10: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/10.jpg)
FDA Plan
• Internal documents developed
• Ongoing discussion
• Very complicated issues
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FDA Plan
• Central issue is risk assessment
• Challenging issue for SACGT
• Challenging issue for FDA
• Input expected from outside groups
• Input welcome
![Page 12: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/12.jpg)
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
![Page 13: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/13.jpg)
Statutory/Regulatory Limitations
• All devices have limitations to exemption
• Even microarrays that might satisfy description of ASR classifications may trip limitations
![Page 14: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/14.jpg)
Extensive Discussion
• Nuanced issues
• Complex issues
• FDA commitment to clarify
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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
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De Novo 510(k)s
• Flexible option when appropriate• Fast option when needed• Broad option -- TDM Round Table
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FDA Revisit of ASRs
• Not focused on genetic testing alone
• Part of overall risk management initiatives without genetic exceptionalism
• Likely to take time
![Page 18: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/18.jpg)
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
![Page 19: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/19.jpg)
Alternative Review Models
• IVAT
• TPLC model
![Page 20: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/20.jpg)
Alternative Review Models
• IVAT – dockets open
• TPLC model – internal to Round Table
• Public Discussion -- minutes
![Page 21: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/21.jpg)
Alternative Review Models
• Common core issues
• Comport to public health mission
• Comport to law
![Page 22: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/22.jpg)
IVAT Model
• Well established, classified analytes is the norm
• Clear intention is for more novel subsets
![Page 23: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/23.jpg)
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?
![Page 24: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/24.jpg)
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
![Page 25: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/25.jpg)
TPLC Model
• Challenge to refine and illuminate by example
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Change in Review Practice
• More incremental
• Based on current tools
• Not challenge regulations or statutes
![Page 27: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/27.jpg)
Template Based Review
• Posting review memos
• Home made template
• Work backwards
• Create turbo 510(k)
![Page 28: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/28.jpg)
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
![Page 29: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/29.jpg)
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
![Page 31: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/31.jpg)
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
![Page 32: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/32.jpg)
SARS
• CDC IDE
• De novo West Nile
• SARS workshop
• SARS guidance on hold – sort through complex issues
• Working with companies individually -- build experience needed
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Informed Consent
• No OIVD level activity in this area
• Does industry plan to weigh in
• Changing environment
• Current recommendations -- talk to your IRB
![Page 34: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/34.jpg)
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
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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
![Page 36: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/36.jpg)
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
![Page 37: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/37.jpg)
OIVD Objectives
• Not unique
• Use Fee Goals
• TPLC
• Contribute to Commissioner’s Strategic Plan
![Page 38: OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to.](https://reader035.fdocuments.in/reader035/viewer/2022062517/56649ed15503460f94bdfaa1/html5/thumbnails/38.jpg)
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!