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OIVD Workshop Premarket Notification (510(k)) April 22, 2003 Parklawn Building Rockville, MD

OIVD Workshop Premarket Notification (510(k)) April 22, 2003 Parklawn Building Rockville, MD

OIVD Workshop Premarket Notification (510(k)) April 22, 2003 Parklawn Building Rockville, MD Presented by Marjorie Shulman Premarket Notification Staff Office of Device Evaluation Center for Devices and Radiological Health (301) 594-1190 x 144. What is a 510(k)?.

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663 views • 51 slides
510(k) Submissions Recent Experience and Perspectives

510(k) Submissions Recent Experience and Perspectives

510(k) Submissions Recent Experience and Perspectives. Terry Sullivan Vice President, Regulatory Affairs. What I will cover today. Survey of audience Overview of 510(k) pathways Traditional Special Abbreviated Perspective on some options available to manufacturers STED

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318 views • 21 slides
510(k) Submissions Recent Experience and Perspectives

510(k) Submissions Recent Experience and Perspectives

510(k) Submissions Recent Experience and Perspectives. Terry Sullivan Vice President, Regulatory Affairs. What I will cover today. Survey of audience Overview of 510(k) pathways Traditional Special Abbreviated Perspective on some options available to manufacturers STED

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215 views • 21 slides
Lighter-Than-Air Flying Devices

Lighter-Than-Air Flying Devices

Lighter-Than-Air Flying Devices. Background. Vehicles designed to travel through air are termed aircraft. There are two types of aircraft: 1. those that fly through the air 2. those that float in air. Hot air balloons and helium airships float in air.

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467 views • 15 slides
Classification of HLA Devices FDA Recommendations & Questions

Classification of HLA Devices FDA Recommendations & Questions

Classification of HLA Devices FDA Recommendations & Questions. Sheryl A. Kochman CBER/OBRR/DBA. Where Do HLA Devices Fit?. Current CBER review incorporates special controls performance standards, e.g. 80% concordance special labeling requirements recommendations Device is moderate-risk

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133 views • 5 slides
F AILURE M ODE E FFECT A NALYSIS

F AILURE M ODE E FFECT A NALYSIS

F AILURE M ODE E FFECT A NALYSIS. INTRODUCTION. INTRODUCTION.

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161 views • 5 slides

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