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  Medical Device Regulation Basics

Medical Device Regulation Basics

 

 

Table of Contents

Chapter


Title


Page


1 Medical Devices 1
2 The Laws in General 2
3 Prohibited Acts 3
4 Device Registration and Listing Requirements 5
5 Imports 6
6 Exports 7
7 Interstate Shipments 8
8 Classification of Devices 9
9 Pre-market Notification [510(k)] 12
10 Pre-market Testing and Approvals 17
11 Good Manufacturing Practice Regulation
(21 CFR 820 - Quality System Regulation)
18
12 Medical Device Reporting 19
13 FDA Recall Authority 20
14 Tracking Requirements 21
15 Removal or Correction 22
16 Post-market Surveillance 23
17 Banned Devices 24
18 Investigational Device Exemptions 25
19 Humanitarian Devices 26
20 Custom Devices 27
21 Pre-market Approval (PMA) 28


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