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
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