Classification of HLA Devices FDA Introduction & Background

9/14/00


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Table of Contents

Classification of HLA Devices FDA Introduction & Background

Objectives

What are “HLA Devices”?

What are “HLA Devices”? (cont’d)

What are NOT “HLA Devices”?

Regulatory History

Effect of Proposed and Final Rules

Effect of Proposed and Final Rules

Subsequent Regulatory Process

Basis for Confusion

Problems Associated With Lack of Classification

Device Classification Preamendments Devices

Class I

General Controls

Class I

Class II

Special Controls

Class II

Class III

Premarket Approval

Class III

Device Classification Postamendments Devices

Substantial Equivalence

Author: CBER