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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. Forum for open discussion

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Global Harmonization of Medical Device Regulation: Accomplishments, Challenges and Opportunities

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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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?

  6. Taking the Task Force Forward • Guidance Implementation • Audits • NCAR • Organizational Logistics • Web redesign • More languages • Expansion • Organizational • Training and dialogue

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