Medical Device Development Tools: FDA CDRH Pilot Program Kathryn O‘Callaghan Senior Science Health...
28
Medical Device Development Tools: FDA CDRH Pilot Program Kathryn O‘Callaghan Senior Science Health Advisor Office of the Center Director FDA CDRH MDIC M&S Summit Washington, DC June 26, 2014 Tina Morrison Regulatory Advisor, Computational Modeling Office of Device Evaluation FDA CDRH
-
Upload
easter-kelly -
Category
Documents
-
view
215 -
download
0
Transcript of Medical Device Development Tools: FDA CDRH Pilot Program Kathryn O‘Callaghan Senior Science Health...
Medical Device Development Tools:FDA CDRH Pilot Program
Kathryn O‘Callaghan
Senior Science Health Advisor
Office of the Center Director
FDA CDRH
MDIC M&S SummitWashington, DC
June 26, 2014
Tina Morrison
Regulatory Advisor, Computational Modeling
Office of Device Evaluation
FDA CDRH
Medical Device Development
The Total Product Life Cycle
CMS REIMBURSEMENT
POSTMARKET
MONITORING
CMSEVALUATION
CMSREIMBURSE
DECISION
REAL-WORLDPRODUCT
PERFORMANCE
FDAREGULATORY
DECISION
PRODUCTLAUNCH
CLINICAL
PRE-CLINICALINVENTION
+PROTOTYPING
DISCOVERY+
IDEATION
NEXT GENERATION
PRODUCT DEVELOPMENT
More PredictableMore Efficient
Regulatory Science Efforts
Device Development & Regulatory Evaluation
3
Animal Bench-top
Human Computer
Proposed New Voluntary Program
4http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm374427.htm
TODAY: Tools considered and evaluated on a case-by-case
basis
TOMORROW: Qualified for regulatory purposes, within
a defined context of use
MDDT
MDDTMDDT
MDDT
Case-by-case…
Why is FDA CDRH developing a qualification process?
KEY CONCEPTS
6
Types of Tools (Categories)
MDDT Qualification
Clinical Outcome Assessments
Biomarker Tests
Nonclinical Assessment Models
What is “FDA Qualification”?
The results of an assessment can be relied upon for device development & evaluation, within a specified context of use
Device industry need not reconfirm the suitability of a qualified MDDT
Device industry users may need to demonstrate the tool is used according to the specified context of use
Context of use ≈ boundaries within which evidence & justification supports tool use
8
Context of Use
Device or Product
Area
Specific Role of the
MDDT
Stage of Developme
nt
9
Context of Use:Clinical Roles for MDDT
Clinical Study
Endpoints
Patient Selectio
n
Aid in Diagnosi
s
10
Context of Use:Non-Clinical Roles for MDDT
11
Substitute for animal or human studies
Minimize use of animals
Reduce test
duration or sample
size
Strength of Evidence Needed Depends on Context of Use
Stages of Product Development
Invention & Prototyping
Early Development
Clinical / Regulatory Evaluation
Clinical Care (Practice Guidelines)
Next Steps:Pilot Program
13
Considerations for CDRH Qualification
Tool Context of Use
Strength of Evidence
Advantages & Disadvantages
14
Threshold for CDRH Qualification
Key Criteria:Description of MDDT. Is the MDDT adequately described?Context of use. Is the context of use adequately and appropriately defined?Strength of evidence. Tool validity, scientific plausibility, extent of prediction & capture.Advantages & disadvantages.
15
The strength of evidence needed to support qualification depends largely on the context of use.
Computational Models
For computational models that are MDDTs, we will leverage the Credibility Strategy as part of the qualification process
Credibility: the quality to elicit belief or trust in predictions of the CM&S within a context of use
The strategy is a tool for systematic identification of ‘how much’ VVUQ is necessary to support the CM&S in a specific context of use.
16
Computational Models
17
Availability of MDDTs in the Pilot Program
Transparency: For qualified MDDT, FDA will make public the context of use, and a summary of evidence and basis of the qualification determination (analogous to summaries of approved devices). FDA will keep proprietary information confidential.
Accessible to public: Submitter must consent to make MDDT accessible to the public for use, and not restrict to certain private entities, such as a single manufacturer
Licensing/pricing/IP: FDA and the MDDT program places no requirements on licensing/cost/degree of access to IP associated with a tool, nor does it consider restrictions related to patent claims. An MDDT submitter may include and protect proprietary methods, as long as access to the tool is not restricted to certain private entities.
18
WHY PARTICIPATE?
19
Benefits to Medical Device Manufacturers & FDA
Goal – Qualification will facilitate:More predictable product evaluation. Medical device industry can use qualified tools without the need to reconfirm validity in individual submissions to FDA, potentially reducing time and other resources needed to develop new products.
More efficient regulation. FDA’s efforts to qualify one MDDT could by surpassed by the time and resources saved when the MDDT is applied to several device submissions or device development programs.
21
Benefits to Tool Developers
Goal – Publicizing MDDT qualification determinations will foster:
Adoption. Encourage adoption of tools
Transparency. Allow the FDA to more quickly and clearly communicate about important advances in regulatory science
Collaboration. Facilitate collaboration in a pre-competitive setting to amplify evidence collection and reduce individual resource expenditure
TODAY: Tools considered and evaluated on a case-by-case
basis
TOMORROW: Qualified for regulatory purposes within a
defined context of use
MDDT
MDDTMDDT
MDDT
Case-by-case…
Bridging Advances in Regulatory Science into Regulatory Application
Upcoming Meetings
ASME V&V40 SubcommitteeJuly 29-30, 2014, FDA Campus
Medical Device Special Interest Group with the Biomedical Engineering Society
Annual Meeting: October 22-25, 2014, San Antonio, TX
SIG Session on 10/23
BMES/FDA Modeling and Simulation ConferenceFormerly known as the ASME/FDA Frontiers Conference
May 18-20, 2015, University of Maryland
23
Contact Information
Tina Morrison
(301) 796-6310
Katie O’Callaghan
(301) 796-6349
FAQ: Examples of Tools Eligible to be Qualified
PRO rating scales, such as those for pain, symptom relief, function, improved mobility, or health status (also commonly referred to as “quality of life”)
Clearly defined clinical outcomes based on subjective clinical decision-making if used as a measure of treatment benefit, such as heart-failure related hospitalization
Nonclinical Assessment Models developed to measure a parameter of interest or to substitute for another generally accepted test or measurement, such as:
Computer modeling to assess conditions typically evaluated through human, animal or bench testing
In vitro models to replace animal testing
Use of tissue and other material phantoms to evaluate imaging devices25
26
FAQ: Proposals
Proposal streams: An MDDT developer chooses to pursue qualification to allow for use of the tool across multiple device programsFDA identifies an area of need or calls for development activity in a specific areaNeed and interest in an area is determined by individual or consortia of stakeholders (e.g., MDIC)
FAQ: Factors for Prioritization
1. Public health impactContext of use includes life-threatening AND/OR serious chronic disease/conditionNo/poor alternatives or unmet scientific need
2. Benefit for innovation or efficiencyDevice area includes novel or innovative technology with no established regulatory paradigmMajor efficiencies to be gained
3. Scope of impact: Potential for use by multiple product development programs or sponsors
27
FAQ: Voluntary Program
Opt-in policy. Medical device manufacturers may use qualified MDDT but are not required to do so*Tool developers may pursue FDA qualification but are not required to do so* Medical device manufacturers may still elect to pursue confidential use of a tool within a specific application only*
*See preceding benefits slides!
28
