CDRH Vision - Total Product Life Cycle

2/7/02


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Table of Contents

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CDRH Vision - Total Product Life Cycle

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CDRH Science Review

Broad Areas of Focus: CDRH Internal & External Reviews

Internal Review

“Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

“Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

“Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

“Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

“Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

“Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

“Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

“Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

“Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

“Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

Evaluation of External Review

CDRH Science Review Evaluation

CDRH Science Review Evaluation

CDRH Science Review Evaluation

CDRH Science Review Evaluation

CDRH Science Review Evaluation

What was the best/most useful activity or component of the Science Review?

What was the worst/least useful activity or component of the Science Review?

Which of the Committee’s recommendations do you believe: CDRH must address in the near term to address a critical flaw?

Which of the Committee’s recommendations do you believe: CDRH must address to assure our place as a scientific leader in the medical device community?

Science Review Next Steps

CDRH Science Recommendations Committee

Science Review Next Steps

Science Review Next Steps

CDRH Science Review Committee

New Technology

New Technology

New Technology

New Technology

New Technology

Center for Devices and Radiological Health

Center for Devices and Radiological Health

“Top 10 list” of the greatest challenges and problems for science-based regulation at CDRH

“Top 10 list” of recommendations for science-based regulation at CDRH

Author: David William Feigal