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Global Harmonization of Medical Device Regulation: Accomplishments, Challenges and Opportunities. Larry Kessler, Sc.D. Director Office of Science and Engineering Laboratories CDRH, FDA Chair, Global Harmonization Task Force. Accomplishments to Date. Forum for open discussion

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Global harmonization of medical device regulation accomplishments challenges and opportunities
Global Harmonization of Medical Device Regulation: Accomplishments, Challenges and Opportunities

  • Larry Kessler, Sc.D.

  • Director

  • Office of Science and Engineering Laboratories

  • CDRH, FDA

  • Chair, Global Harmonization Task Force


Accomplishments to date
Accomplishments to Date

  • Forum for open discussion

  • Development of harmonized guidance

  • Interaction with other organizations

  • Education for nations with emerging systems

  • Emerging technologies and related issues


Ghtf challenges
GHTF Challenges

  • Differing regulatory paradigms

  • Maturity of systems varies

  • Significant cultural differences

  • Incorporating non-binding “guidance” into legislation and/or regulation difficult for FDA in short time period

  • When to emphasize emerging issues


Specific challenges
Specific Challenges

  • Premarket authorization

    • Essential principles conformance vs. review

  • Postmarket surveillance

    • Mature system in the US many reports vs. “case study” approach

  • Quality Systems

    • Incorporating risk management

  • Auditing

    • Format

    • Depth of Audit


Let s talk turkey obstacles
Let’s Talk Turkey: Obstacles

  • Regulatory organizations must harmonize

    • Agencies have not moved their process

    • Public declaration vs. de facto practice

  • Industry must get engaged

    • Summary Technical Evaluation Document not used often: highest or lowest denominator?

    • Few volunteers for joint inspections: concern about impact of one bad inspection?


Taking the task force forward
Taking the Task Force Forward

  • Guidance Implementation

    • Audits

    • NCAR

  • Organizational Logistics

    • Web redesign

    • More languages

  • Expansion

    • Organizational

    • Training and dialogue


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