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U.S. Department of Health and Human Services

Combination Products

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Meetings, Conferences, & Workshops

Jurisdictional Decision Support Tool by Mark Hamblin, Carnegie Mellon University

Slide 1 - Jurisdictional Decision Support Tool

Mark Hamblin

Carnegie Mellon University

Slide 2 - Public Policy Project Course

  • Tissue Engineering
  • Navigating the FDA approval process
  • Social and ethical issues
  • Financial and marketing issues
  • Jurisdictional determination
    • Review of current process
    • Review of inter-center agreements
    • Creation of web-based decision support tool

Slide 3 - Current Jurisdiction Process

  • Intercenter Agreements provide rules for classifying combination products, but are too focused in scope
    • Only cover existing technologies
  • Intercenter Agreements may not apply to new technologies
  • Jurisdiction determination is then based only on the “primary mode of action”, of which no clear definition exists
  • Some subjectivity is necessary to reach a decision, yielding a lack of consistency, predictability, and transparency

Slide 4 - Purpose of Decision Support Tool

  • Create a rule based system that classifies medical products based on product characteristics
  • Incorporate previously established jurisdiction rules from Intercenter Agreements
  • Add additional criteria for determining jurisdiction to fill in the gaps
  • Allow for easy adaptability and variability to accommodate current FDA regulatory requirements and trends
  • Make the tool widely available (web-based) to allow for greater transparency and predictability in jurisdictiondetermination process

Slide 5 - Details of Decision Support Tool

  • Each product has 3 “pools of points”, one each for each of the three FDA regulatory centers
  • List of 88 yes/no questions pertaining to product characteristics
    • If “yes” for a question, X points go to pool 1, Y points go to pool 2, Z points go to pool 3
    • Each question has a weight from 0 to 1 based on how important that question is in the overall classification scheme
    • Points for each pool get scaled based on the weight for that question
  • Product gets classified into the respective center based on the “pool” that has the most points
  • Easy to change classification scheme by changing respective weights of questions and point distributions

Slide 6 - Creating Model Inputs

  • Extracted 67 questions from the rules in the Intercenter Agreements
  • Conducted a survey of tissue engineering experts
    • Sent to 205 members of the Pittsburgh Tissue Engineering Initiative
    • Proposed 21 different product characteristics
      • Surveyed how the experts thought the presence of these characteristics should affect classification
      • Created 21 questions for the model based on these product characteristics
      • Assigned points for the model based on the survey responses
    • Also gathered responses regarding experiences and opinions of FDA jurisdictional decision process and approval process

Slide 8 - How It Helps

  • Intercenter Agreements form a precedent based decision model by looking only at specific characteristics of previously developed products
  • Precedent based decision models typically are not optimal for classifying new types of products
    • Too subjective
  • Proposed decision support tool is a rule based model that looks at a product’s general characteristics
    • More applicable to future products and technology
  • Widely accessible rule based decision model will provide a consistent, predictable, and transparent method for classification problems

Slide 9 - Final Presentation and Report

  • Final presentation to be given in Washington DC on Wed. December 4, 2002
  • Members of review panel include senior management from FDA, academic and industry researchers, other stakeholders
  • Publication of written report expected in January 2003
  • Contact mhamblin@andrew.cmu.edu for details on final presentation or written report